Meningococcal DiseasePhase 2/3NCT00661713

Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules

A Phase 2/3 study testing rMenB+OMV NZ in people with Meningococcal Disease, run by Novartis Vaccines at 10 sites in Chile.

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 is aimed to assess the antibody response and short-term persistence of Novartis Meningococcal B Vaccine after one, two or three doses and to evaluate the optimal vaccination schedule in an adolescent population. Read more about this study

Who is it for?: Ages 11 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Meningococcal Disease
What is being tested?: rMenB+OMV NZ
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,631 participants
Where: 10 sitesChile
Study dates: Jun 2008to Dec 2010
Phase: Phase 2/3
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 11 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

1)11-17 years of age inclusive who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment;
2)who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period);
3)in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Who cannot join

History of any meningococcal B vaccine administration;
Current or previous, confirmed or suspected disease caused by N. meningitidis;
Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥38°C) within the previous day;
Antibiotics within 6 days prior to enrollment;
Pregnancy or nursing (breastfeeding) mothers;

Show all 15Show fewer

Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the 7 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device 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;
Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, HIV infection or 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, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids within the previous 60 days. [Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body is allowed]; immunostimulants;
Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
Receipt of or intent to immunize with any other vaccine(s) within 30 days prior (60 days for live viral vaccines) and throughout the study period (exception: licensed fluvaccine should not be administered within 14 days prior to enrollment; routine vaccine administration may be administered after the blood draw at Study Month 7);
Participation in another clinical trial within the last 90 days or planned for during study;
Family members and household members of research staff;
Any condition which in the opinion of the investigator and/or the Regional MD may interfere with the evaluation of the study objectives.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Chile10 sites

Site 41: Colegio Antonio Hermida Fabres
Av. Coronel Alejandro Sepúlveda N° 6801
Site 43: Liceo José Victorino Lastarria
Av. Miguel Claro N° 32
Site 51: Centro Para vacunas en Desarrollo. Hospital de Niños Roberto del Rio
Av. Prof Zañartu 1085
Site 15: Liceo Carmela Carvajal de Prat
Avda. Italia 980
Site 14: Colegio Parroquial Santa Rosa de Lo Barnechea
Avda. Raúl Labbé Nº 13.799
Site 42: Centro Educacional Eduardo de la Barra
Calle A, N° 6301
Site 61: Facultad de Medicina. Universidad de Valparaíso.
Hontaneda # 2653. Valparaíso
Site 11: Complejo Educacional Eduardo Cuevas Valdés
Lo Barnechea
Site 13: Liceo Diego Aracena de Lo Barnechea
Monseñor Escrivá de Balaguer 14630, Lo Barnechea, Santiago Metropolitan
Site 12: Colegio San Jose de Lo Barnechea
Santiago

Other trials in Chile

About this study

Official title: A Phase 2b/3, Multi-Center, Observer-Blind, Controlled Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents Aged 11-17 Years According to Different Vaccination Schedules

Conditions: Meningococcal Disease
Being tested: rMenB+OMV NZ, Placebo
Keywords: Meningococcal disease, Neisseria meningitidis serogroup B, prevention, vaccination, adolescents
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
Also called Serogroup B Meningococcal Vaccine
PlaceboBiological

Study groups in NCT00661713
Study group	Role	What they receive
rMenB06	Experimental	Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and two injections of placebo (at month 1, month 2). A second injection of rMenB+OMV NZ vaccine was given later (month 6). Receives: Biological: rMenB+OMV NZ; Biological: Placebo
rMenB0	Experimental	Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and three injections of placebo (month 1, month 2 and month 6). Receives: Biological: rMenB+OMV NZ; Biological: Placebo
rMenB016	Experimental	Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6). Receives: Biological: rMenB+OMV NZ; Biological: Placebo
rMenB01	Experimental	Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and two injection of placebo (at month 2 and month 6). Receives: Biological: rMenB+OMV NZ; Biological: Placebo
rMenB026	Experimental	Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6). Receives: Biological: rMenB+OMV NZ; Biological: Placebo
rMenB02	Experimental	Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and two injections of placebo (at month 1 and month 6). Receives: Biological: rMenB+OMV NZ; Biological: Placebo
rMenB012	Experimental	Subjects received three injections of rMenB+OMV NZ vaccine (at month 0, month 1 and month 2) and one injection of placebo later (at month 6). Receives: Biological: rMenB+OMV NZ; Biological: Placebo
rMenB6	Experimental	Subjects received three injections of placebo(at month 0, month 1 and month 2) and one injection of rMenB+OMV NZ vaccine(at month 6). Receives: Biological: rMenB+OMV NZ; Biological: Placebo

What is being measured

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

Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 against 44/76-SL, 5/99, NZ98/254 strains at months 1, 2, 3.
Measured: Month-1, 2, 3
Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination
Safety was assessed as the number of subjects who reported local and systemic reactions during day 1 to day 7 after any vaccination with rMenB+OMV
Measured: 1 to 7 days after each vaccination

Secondary outcomes (8)

Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 agains 44/76-SL, 5/99, NZ98/254 strains at months 6 \& 7.
Measured: Month-6 & 7
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titer ≥1:8 against 44/76-SL, 5/99, NZ98/254 strains.
Measured: at baseline, month-1, month-2, month-3, month-6 and month-7.
Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.
Immunogenicity was evaluated by measuring the percentage of subjects with at least a fourfold rise in hSBA titer over the prevaccination and after booster vaccination against 44/76-SL, 5/99, NZ98/254 strains at month-1, month-2, month-3 and month-7.
Measured: Month-1, month-2, month-3 and month-7
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
Immunogenicity was evaluated by measuring the Geometric mean titers (GMTs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.
Measured: month-1, month-2, month-3, month-6 and month-7
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
Immunogenicity was evaluated by measuring the Geometric mean ratios (GMRs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.
Measured: month-1, month-2, month-3, month-6 and month-7
GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.
Immunogenicity was evaluated by measuring the Geometric mean Concentration (GMCs) after primary and booster vaccination against Antigen 287-953 Antigen.
Measured: month-1, month-2, month-3, month-6 and month-7
GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination
Immunogenicity was evaluated by measuring the Geometric mean Ratios (GMRs) after primary and booster vaccination against 287-953Antigen
Measured: month-1, month-2, month-3, month-6 and month-7
Number of Subjects Reporting Unsolicited AEs Throughout the Study.
Safety was assessed as the number of subjects who reported unsolicited AEs throughout the study.
Measured: Throughout the study

Timeline

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

Jun 2008Dec 2010

First posted18 Apr 2008 (estimated)
Study startJun 2008
Primary completionApr 2010
Study completionDec 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 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 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 1,631 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00661713
Sponsor's protocol ID: V72P10
Status last verified: Mar 2019
First submitted: 16 Apr 2008
Last updated: 20 Mar 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

Bartolini E, Borgogni E, Bruttini M, Muzzi A, Giuliani M, Iozzi S, Petracca R, Martinelli M, Bonacci S, Marchi S, Brettoni C, Donati C, Torricelli G, Guidotti S, Domina M, Beninati C, Teti G, Felici F, Rappuoli R, Castellino F, Del Giudice G, Masignani V, Pizza M, Maione D. Immunological fingerprint of 4CMenB recombinant antigens via protein microarray reveals key immunosignatures correlating with bactericidal activity. Nat Commun. 2020 Oct 5;11(1):4994. doi: 10.1038/s41467-020-18791-0.
PubMed 33020485
Santolaya ME, O'Ryan ML, Valenzuela MT, Prado V, Vergara R, Munoz A, Toneatto D, Grana G, Wang H, Clemens R, Dull PM; V72P10 Meningococcal B Adolescent Vaccine Study group. Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b/3 randomised, observer-blind, placebo-controlled study. Lancet. 2012 Feb 18;379(9816):617-24. doi: 10.1016/S0140-6736(11)61713-3. Epub 2012 Jan 18.
PubMed 22260988

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

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Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
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All Meningococcal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2b/3, Multi-Center, Observer-Blind, Controlled Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents Aged 11-17 Years According to Different Vaccination Schedules
ClinicalTrials.gov ID: NCT00661713
Acronym / sponsor ID: V72P10
Conditions: Meningococcal Disease
Keywords: Meningococcal disease, Neisseria meningitidis serogroup B, prevention, vaccination, adolescents
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,631 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Apr 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 18 Apr 2008 (estimated)
Results: Posted 4 Nov 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: Single blind (participant)
Number of arms: 8

Arm	Type	Receives
rMenB06	Experimental	Biological: rMenB+OMV NZ, Biological: PlaceboSubjects received one injection of rMenB+OMV NZ vaccine (month 0) and two injections of placebo (at month 1, month 2). A second injection of rMenB+OMV NZ vaccine was given later (month 6).
rMenB0	Experimental	Biological: rMenB+OMV NZ, Biological: PlaceboSubjects received one injection of rMenB+OMV NZ vaccine (month 0) and three injections of placebo (month 1, month 2 and month 6).
rMenB016	Experimental	Biological: rMenB+OMV NZ, Biological: PlaceboSubjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6).
rMenB01	Experimental	Biological: rMenB+OMV NZ, Biological: PlaceboSubjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and two injection of placebo (at month 2 and month 6).
rMenB026	Experimental	Biological: rMenB+OMV NZ, Biological: PlaceboSubjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6).
rMenB02	Experimental	Biological: rMenB+OMV NZ, Biological: PlaceboSubjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and two injections of placebo (at month 1 and month 6).
rMenB012	Experimental	Biological: rMenB+OMV NZ, Biological: PlaceboSubjects received three injections of rMenB+OMV NZ vaccine (at month 0, month 1 and month 2) and one injection of placebo later (at month 6).
rMenB6	Experimental	Biological: rMenB+OMV NZ, Biological: PlaceboSubjects received three injections of placebo(at month 0, month 1 and month 2) and one injection of rMenB+OMV NZ vaccine(at month 6).

Who may qualify

Ages: 11 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

1)11-17 years of age inclusive who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment;
2)who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period);
3)in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Key exclusion criteria (15 listed)

History of any meningococcal B vaccine administration;
Current or previous, confirmed or suspected disease caused by N. meningitidis;
Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥38°C) within the previous day;
Antibiotics within 6 days prior to enrollment;

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 NZAlso: Serogroup B Meningococcal Vaccine	Biological	rMenB0, rMenB01, rMenB012, rMenB016, rMenB02, rMenB026, rMenB06, rMenB6
Placebo	Biological	rMenB0, rMenB01, rMenB012, rMenB016, rMenB02, rMenB026, rMenB06, rMenB6

Primary outcome

Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
Time frame: Month-1, 2, 3
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 against 44/76-SL, 5/99, NZ98/254 strains at months 1, 2, 3.
Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination
Time frame: 1 to 7 days after each vaccination
Safety was assessed as the number of subjects who reported local and systemic reactions during day 1 to day 7 after any vaccination with rMenB+OMV

8 secondary outcomes

Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.
Time frame: Month-6 & 7
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
Time frame: at baseline, month-1, month-2, month-3, month-6 and month-7.
Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.
Time frame: Month-1, month-2, month-3 and month-7
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
Time frame: month-1, month-2, month-3, month-6 and month-7
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
Time frame: month-1, month-2, month-3, month-6 and month-7
GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.
Time frame: month-1, month-2, month-3, month-6 and month-7
GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination
Time frame: month-1, month-2, month-3, month-6 and month-7
Number of Subjects Reporting Unsolicited AEs Throughout the Study.
Time frame: Throughout the study

Results and safety

Results posted to the registry on 4 Nov 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
rMenB06	128	112
rMenB0	247	208
rMenB016	128	111
rMenB01	247	219
rMenB026	127	107
rMenB02	253	216
rMenB012	373	309
rMenB6	128	117

Primary outcome: Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.

Time frame: Month-1, 2, 3. Number (95% Confidence Interval). Unit: percentage of Subjects

Measure	rMenB06 n = 112	rMenB0 n = 223	rMenB016 n = 113	rMenB01 n = 231	rMenB026 n = 110	rMenB02 n = 232	rMenB012 n = 334	rMenB6 n = 116
44/76-SL- Mo 0	42 (33 to 52)	47 (40 to 54)	41 (32 to 50)	38 (32 to 45)	37 (28 to 47)	47 (40 to 53)	46 (41 to 52)	46 (36 to 55)
44/76-SL- Mo 1	92 (85 to 96)	92 (88 to 95)	95 (89 to 98)	93 (88 to 96)	90 (83 to 95)	92 (88 to 95)	95 (92 to 97)	43 (34 to 53)
44/76-SL- Mo 2	88 (80 to 93)	92 (88 to 95)	100 (97 to 100)	100 (98 to 100)	88 (80 to 93)	89 (85 to 93)	100 (98 to 100)	50 (40 to 59)
44/76-SL- Mo 3	84 (76 to 90)	88 (82 to 92)	99 (95 to 100)	100 (97 to 100)	100 (97 to 100)	100 (98 to 100)	100 (98 to 100)	48 (38 to 58)
5/99- Mo 0	29 (20 to 38)	41 (35 to 48)	28 (20 to 38)	31 (25 to 38)	30 (22 to 39)	37 (31 to 44)	36 (30 to 41)	29 (21 to 38)
5/99- Mo 1	97 (92 to 99)	96 (93 to 98)	96 (90 to 99)	97 (94 to 99)	97 (92 to 99)	95 (92 to 98)	97 (94 to 98)	35 (26 to 44)
5/99- Mo 2	95 (90 to 98)	94 (90 to 97)	100 (97 to 100)	100 (98 to 100)	97 (92 to 99)	96 (93 to 98)	100 (98 to 100)	31 (23 to 41)
5/99- Mo 3	92 (85 to 96)	89 (84 to 93)	99 (95 to 100)	100 (98 to 100)	98 (93 to 100)	100 (98 to 100)	100 (99 to 100)	32 (24 to 42)

Population analysed: Analysis was performed as per the protocol dataset

Primary outcome: Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination

Time frame: 1 to 7 days after each vaccination. Number. Unit: participants

Measure	rMenB06 n = 128	rMenB0 n = 247	rMenB016 n = 128	rMenB01 n = 247	rMenB026 n = 127	rMenB02 n = 253	rMenB012 n = 373	rMenB6 n = 128
erythema (local)	93	162	95	188	94	172	282	85
Induration (Local)	71	130	75	151	82	121	228	57
Swelling (Local)	72	132	81	144	76	115	226	54
Pain (Local)	122	236	124	237	113	236	345	123
Med.Att Fever (Systemic)	1	0	2	0	1	1	1	1
Malaise (Systemic)	92	181	96	172	87	185	272	89
Myalgia(Systemic)	85	141	91	156	81	160	238	91
Arthralgia(Systemic)	55	76	55	80	39	105	146	43

Population analysed: Analysis was performed as per the safety dataset.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
rMenB06	5 of 128 (3.9%)	123 of 128 (96.1%)	Not reported
rMenB0	4 of 247 (1.6%)	238 of 247 (96.4%)	Not reported
rMenB016	2 of 128 (1.6%)	126 of 128 (98.4%)	Not reported
rMenB01	4 of 247 (1.6%)	242 of 247 (98%)	Not reported
rMenB026	2 of 127 (1.6%)	118 of 127 (92.9%)	Not reported
rMenB02	4 of 253 (1.6%)	240 of 253 (94.9%)	Not reported
rMenB012	11 of 373 (2.9%)	354 of 373 (94.9%)	Not reported
rMenB6	3 of 128 (2.3%)	125 of 128 (97.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33020485Bartolini E, Borgogni E, Bruttini M, Muzzi A, Giuliani M, Iozzi S, Petracca R, Martinelli M, Bonacci S, Marchi S, Brettoni C, Donati C, Torricelli G, Guidotti S, Domina M, Beninati C, Teti G, Felici F, Rappuoli R, Castellino F, Del Giudice G, Masignani V, Pizza M, Maione D. Immunological fingerprint of 4CMenB recombinant antigens via protein microarray reveals key immunosignatures correlating with bactericidal activity. Nat Commun. 2020 Oct 5;11(1):4994. doi: 10.1038/s41467-020-18791-0.
Derived from this study: PubMed 22260988Santolaya ME, O'Ryan ML, Valenzuela MT, Prado V, Vergara R, Munoz A, Toneatto D, Grana G, Wang H, Clemens R, Dull PM; V72P10 Meningococcal B Adolescent Vaccine Study group. Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b/3 randomised, observer-blind, placebo-controlled study. Lancet. 2012 Feb 18;379(9816):617-24. doi: 10.1016/S0140-6736(11)61713-3. Epub 2012 Jan 18.

Related trials for Meningococcal Disease

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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 study chair

Novartis Vaccines

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing rMenB+OMV NZ in people with Meningococcal Disease, run by Novartis Vaccines at 10 sites in Chile.

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 3 inclusion and 15 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 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Chile. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 4 Nov 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?

Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine. (time frame: Month-1, 2, 3). 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 NCT00661713, 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 20 Mar 2019.