Meningococcal MeningitisPhase 2NCT00937521

Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants

A Phase 2 study testing Meningococcal B vaccine and Meningococcal B vaccine with antipyretic in people with Meningococcal Meningitis and Meningococcal Infections, run by Novartis Vaccines at 38 sites in 5 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

This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine. Read more about this study

Who is it for?: Ages 55 to 89 daysHealthy volunteers can take part
Conditions the study is for: Meningococcal Meningitis, Meningococcal Infections
What is being tested?: Meningococcal B vaccine and Meningococcal B vaccine with antipyretic
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,507 participants
Where: 38 sitesin 5 countries
Study dates: Jul 2009to Feb 2012
Phase: Phase 2
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), born after full term pregnancy, gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg
Available for all the visits scheduled in the study and for whom a parent/legal guardian is willing/able to comply with all protocol requirements

Who cannot join

Any meningococcal B or C vaccine administration
Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and Pneumococcal antigens;
Any ascertained or suspected disease caused by N. meningitidis
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis
History of severe allergic reaction after previous vaccinations
Recent significant acute or chronic infection

Show all 17Show fewer

Oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw;
Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition)
Any impairment/alteration of the immune system resulting from (for example):
Receipt of any immunosuppressive therapy at any time since birth
Receipt of immunostimulants at any time since birth
Use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids at any time since birth
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
Participation in another clinical trial
Family members and household members of research staff
History of seizure
Any contraindication to paracetamol

Trial locations and contacts

38 sites in 5 countries.

Country

City, postcode or hospital

38 sites in 5 countries

Czechia18 sites

Samostatna ordinace praktickeho lekare pro deti a dorost
Chrudimska 2a, Praha 3, 130 00
Prakticky lekar pro deti a dorost
Dvouletky 54, Ostrava, 700 30
Fakultni nemocnice Bory
E. Beneše 13, Plzeň, 305 99
Samostatna ordinace praktickeho lekare pro deti a dorost
Hrnčířská 1401, Lipník Nad Bečvou, 751 31
Samostatna ordinace praktickeho lekare pro deti a dorost
Kladenská 53, Praha 6, 160 00
Nemocnice Pardubice, Destske odděleni
Kyjevská 44, Pardubice, 532 03
Samostatna ordinace praktickeho lekare pro deti a dorost
Masarykova 389, Humpolec, 396 01
KHS Ostrava, Protiepidemické oddělení
Na Bělidle 7, Ostrava, 702 00
Samostatna ordinace praktickeho lekare pro deti a dorost
Neklez 3, Brno, 628 00
Samostatna ordinace praktickeho lekare pro deti a dorost
O. Kubina 17, Boskovice, 680 01
Samostatna ordinace praktickeho lekare pro deti a dorost
Pernštýnská 127/l, Chlumec Nad Cidlinou, 503 51
Oblastni nemocnice Nachod, Destske oddělení
Purkyňova 446, Náchod, 547 01
Samostatna ordinace praktickeho lekare pro deti a dorost
Ruských Legii 352, Jindřichův Hradec, 377 01
Fakulta vojenskeho zdravotnictvi UO
Trebešská 1575, Hradec Králové, 50001
Samostatna ordinace praktickeho lekare pro deti a dorost
U Lékárny 306, Odolena Voda, 250 70
Nemocnice Decin, Detske oddělení
U Nemocnice 1, Děčín, 405 01
Zdravotní středisko
Vaclavska 4186, Chomutov, 430 03
Samostatna ordinace praktickeho lekare pro deti a dorost
Velka Michalska 22, Znojmo, 669 00

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Hungary11 sites

Medszolg 2000 Bt, 6723, Szeged, Dandár u.4
Ányos U.4., Budapest, 1031
Győriné dr. Bari Eszter egyéni vállalkozó
Csongrád, Szentháromság Tér 10
S.K. Sipka és Kovács Eü. Bt.
Csongrádi Sgt. 63., Szeged, 6723
Oszila Kft. 6723, Szeged, Debreceni u.10-14.
Debreceni U.10-14., Szeged, 6723
Ped-Med Kft. , 3434 Mályi, Fő u.12.
Fő U.12., Mályi, 3434
Erzsébet Kórház Gyermekosztály
Hódmezővásárhely, Dr. Imre József U.2.
Házi Gyermekorvosi szolgálat
Honvéd U.2., Bordány, 6795
Dr. Bán Mariann és Társa Bt.
Kando Kalman U.1, Miskolc, 3534
Vas Megyei Markusovszky Kórház, Gyermekosztály
Markusovszky U. 1-3, Szombathely, 9700
Futurnest Kft
Selyemrét U.1., Miskolc, 3527
Baby Box Bt,, 6724, Szeged, Kossuth Lajos sgt.109
Szeged, Kossuth Lajos Sgt.109

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Italy6 sites

Dipartimento di Neonatologia e Terapia Intensiva Neonatale, "Ospedale dei Bambini", Presidio Ospedaliero dell'Azienda Ospedaliera Spedali Civili di Brescia
P.le Spedali Di Brescia,1, Brescia, 25125
Fondazione IRCCS dell'Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena di Milano
Via Commenda, 9, Milano, 20122
Università degli Studi di Messina, Pad. NI - A.O.U. Policlinico G.Martino
Via Consolare Valeria, 1, Messina, 98125
Pediatria dell'Ospedale Sacco di Milano
Via G.B.Grossi 74, Milano, 20157
Dipartimento di Pediatria Azienda Ospedaliera di Padova
Via Giustiniani, 3, Padova, 35128
Dipartimento di Pediatria dell'Università degli Studi di Firenze
Viale Pieraccini N. 24, Firenze, 50139

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Chile2 sites

Universidad de Chile, Av Independencia 1027
Comuna de Independencia, Santiago Metropolitan
Consultorio Manuel Bustos
Lo Cruzat 486, Quilicura, Santiago Metropolitan

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Argentina1 site

Hospital Privado de Córdoba CMC SA
Naciones Unidas 346, Córdoba Province, X5016KHE

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About this study

Official title: A Phase 2 Partially Observer-Blind Randomized Controlled Multicenter Dose-Ranging and Formulation-Finding Study of a New Novartis Meningococcal B Recombinant Vaccine Evaluating the Safety and Immunogenicity When Given Concomitantly With Routine Vaccines in 2-month-old Infants

This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine.

Conditions: Meningococcal Meningitis, Meningococcal Infections
Being tested: Meningococcal B vaccine, Control, Meningococcal B vaccine with antipyretic
Keywords: Immunogenicity, Meningitis, Antibody, Infants
Medical subject headings: Meningitis, Meningococcal, Meningococcal Infections, Meningitis

What participants receive

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

Meningococcal B vaccineBiological
Vaccine candidate formulation I
Meningococcal B vaccineBiological
Vaccine candidate formulation II
Meningococcal B vaccineBiological
Vaccine candidate formulation III
Meningococcal B vaccineBiological
Vaccine candidate formulation IV
Meningococcal B vaccineBiological
Vaccine candidate formulation V
Meningococcal B vaccineBiological
Vaccine candidate formulation VI
ControlBiological
Control
Meningococcal B vaccine with antipyreticBiological
Vaccine candidate formulation I with antipyretic

Study groups in NCT00937521
Study group	Role	What they receive
1	Other	Vaccine candidate formulation I Receives: Biological: Meningococcal B vaccine
2	Other	Vaccine candidate formulation II Receives: Biological: Meningococcal B vaccine
3	Other	Vaccine candidate formulation III Receives: Biological: Meningococcal B vaccine
4	Other	Vaccine candidate formulation IV Receives: Biological: Meningococcal B vaccine
5	Other	Vaccine candidate formulation V Receives: Biological: Meningococcal B vaccine
6	Other	Vaccine candidate formulation VI Receives: Biological: Meningococcal B vaccine
7	Other	Control Receives: Biological: Control
8	Other	Vaccine candidate formulation I with antipyretic Receives: Biological: Meningococcal B vaccine with antipyretic

What is being measured

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

Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination
To assess the immunogenicity of seven different formulations of 4CMenB (groups I-VI and VIII) given to healthy infants at 2,3 and 4 months of age as measured by percentages of subjects with serum bactericidal activity (SBA) titer≥1:5 against 44/76-SL, 5/99 and NZ98/254 reference strains, at 1 month after the third vaccination.. The analysis was done on the Per Protocol Primary Population at one month after third injection.
Measured: At baseline (pre-vaccination) and 30 days after the third vaccination.
Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination
To assess if any of six different formulations of vaccine groups (Group II to Group VI, Group VIII) reduced the incidence of fever >=38.5C (rectal) occurring within three days (day 1-day3) following first vaccination. The analysis was done on the Safety Population.
Measured: Day 1 to day 3 after first vaccination.

Secondary outcomes (13)

Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
ToTo assess the immune response of seven different formulations of meningococcal multi-component recombinant, adsorbed vaccine (rMenB+OMV NZ or rMenB (no OMV)) in healthy toddlers as measured by SBA geometric mean titers (GMTs) at:
1. One month after third vaccination.
2. One month after booster vaccination (Men B at 12 months of age).
Measured: At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age)
Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
To compare the antibody response of meningococcal multi-component recombinant, adsorbed vaccine (formulation I vs. formulation VIII) and of routine infant vaccine given with or without prophylactic administration of paracetamol medication in healthy toddlers.
Measured: At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days
Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
To compare the antibody response between meningococcal multi-component recombinant adsorbed vaccine (formulation I) and routine infant vaccine group along with meningococcal multi-component recombinant adsorbed vaccine with prophylactic administration of paracetamol medication as measured by Geometric Mean Ratios (GMRs).
Measured: After the third and the booster vaccination.
Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose)
To assess the persistence of bactericidal antibodies at 12 months of age after primary vaccination - three doses of one of the seven different formulations of rMenB+OMV NZ or rMenB (no OMV) (Group I-VI and VIII) and rMenB+OMV NZ with paracetamol medication.
Measured: 12 months (pre-fourth vaccination)
Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose)
To assess if any of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (groups I-VI and VIII) induced sufficient immune response when given to healthy toddlers at 12 months of age, as measured by percentage of subjects with SBA titer ≥ 1:5, at 1 month after the fourth vaccination.
Measured: 1 month after fourth vaccination
Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age)
To assess the induction of immunological memory of three doses of meningococcal multi-component recombinant, adsorbed vaccine by comparing the serum bactericidal antibodies Geometric Mean Bactericidal Titers (GMTs) response in healthy toddlers administered the fourth dose at 12 months of age to the response in meningococcal B vaccine naive toddlers (Group VII) receiving the first dose of meningococcal multi-component recombinant, adsorbed vaccine at 12 months of age.
Measured: At 13 months
Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster)
To assess the immune response of first dose of meningococcal multi-component recombinant, adsorbed vaccine given at 12 months of age to toddlers who previously received three doses of MenC-CRM197 vaccine as infants (group VII).
Measured: 1 month after booster
Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination
To assess if any of six different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (Group II to VI, Group VIII) reduced the incidence of fever ≥ 38.5ºC (rectal) occurring within 3 days (day 1-3) following second and third vaccination and 7 days (day 1-7) following each vaccination as compared to rMenB+OMV NZ (Group I).
Measured: Day 1 through day 7 after second and third vaccination.
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited local reactions within 7 days (day 1-7) after each vaccination.
Measured: Day 1 through day 7 after each vaccination.
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited systemic reactions within 7 days (day 1-7) after each vaccination.
Measured: Day 1 through day 7 after each vaccination.
Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting unsolicited Adverse Events (AEs), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period) within 7 days (day 1-7) after each vaccination.
Measured: Day 1 through day 7 after each vaccination.
Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period.
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting Severe Adverse Events (SAEs) and Adverse Events (AEs) necessitating a medical office or Emergency Room (ER) visit and/or resulting in premature withdrawal of the subject from the study, throughout the study period.
Measured: Overall study period.
Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
To assess the safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group VII) given at 12 and 13 months of age to toddlers who previously received three doses of Menjugate as infants.
Measured: Day 1 through day 7 at 13 months age.

Timeline

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

Jul 2009Feb 2012

First posted13 Jul 2009 (estimated)
Study startJul 2009
Primary completionNov 2010
Study completionFeb 2012

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 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 1,507 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00937521
Sponsor's protocol ID: V72P16
Other IDs: 2009-010106-11, 2009
Status last verified: Mar 2015
First submitted: 29 Jun 2009
Last updated: 7 Apr 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Viviani V, Biolchi A, Pizza M. Synergistic activity of antibodies in the multicomponent 4CMenB vaccine. Expert Rev Vaccines. 2022 May;21(5):645-658. doi: 10.1080/14760584.2022.2050697. Epub 2022 Mar 14.
PubMed 35257644
Esposito S, Prymula R, Zuccotti GV, Xie F, Barone M, Dull PM, Toneatto D. A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in infants (II). Hum Vaccin Immunother. 2014;10(7):2005-14. doi: 10.4161/hv.29218.
PubMed 25424810

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 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Partially Observer-Blind Randomized Controlled Multicenter Dose-Ranging and Formulation-Finding Study of a New Novartis Meningococcal B Recombinant Vaccine Evaluating the Safety and Immunogenicity When Given Concomitantly With Routine Vaccines in 2-month-old Infants
ClinicalTrials.gov ID: NCT00937521
Acronym / sponsor ID: V72P16
Conditions: Meningococcal Meningitis, Meningococcal Infections
Keywords: Immunogenicity, Meningitis, Antibody, Infants
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,507 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Nov 2010 (actual)
Study completion: Feb 2012 (actual)
First posted: 13 Jul 2009 (estimated)
Results: Posted 4 Mar 2015

Clinical summary

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

This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 8

Arm	Type	Receives
1	Other	Biological: Meningococcal B vaccineVaccine candidate formulation I
2	Other	Biological: Meningococcal B vaccineVaccine candidate formulation II
3	Other	Biological: Meningococcal B vaccineVaccine candidate formulation III
4	Other	Biological: Meningococcal B vaccineVaccine candidate formulation IV
5	Other	Biological: Meningococcal B vaccineVaccine candidate formulation V
6	Other	Biological: Meningococcal B vaccineVaccine candidate formulation VI
7	Other	Biological: ControlControl
8	Other	Biological: Meningococcal B vaccine with antipyreticVaccine candidate formulation I with antipyretic

Who may qualify

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

Key inclusion criteria (2 listed)

Healthy 2-month old infants (55-89 days, inclusive), born after full term pregnancy, gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg
Available for all the visits scheduled in the study and for whom a parent/legal guardian is willing/able to comply with all protocol requirements

Key exclusion criteria (17 listed)

Any meningococcal B or C vaccine administration
Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and Pneumococcal antigens;
Any ascertained or suspected disease caused by N. meningitidis
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis
History of severe allergic reaction after previous vaccinations

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
Meningococcal B vaccineVaccine candidate formulation I	Biological	1
Meningococcal B vaccineVaccine candidate formulation II	Biological	2
Meningococcal B vaccineVaccine candidate formulation III	Biological	3
Meningococcal B vaccineVaccine candidate formulation IV	Biological	4
Meningococcal B vaccineVaccine candidate formulation V	Biological	5
Meningococcal B vaccineVaccine candidate formulation VI	Biological	6
ControlControl	Biological	7
Meningococcal B vaccine with antipyreticVaccine candidate formulation I with antipyretic	Biological	8

Primary outcome

Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination
Time frame: At baseline (pre-vaccination) and 30 days after the third vaccination.
To assess the immunogenicity of seven different formulations of 4CMenB (groups I-VI and VIII) given to healthy infants at 2,3 and 4 months of age as measured by percentages of subjects with serum bactericidal activity (SBA) titer≥1:5 against 44/76-SL, 5/99 and NZ98/254 reference strains, at 1 month after the third vaccination.. The analysis was done on the Per Protocol Primary Population at one month after third injection.
Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination
Time frame: Day 1 to day 3 after first vaccination.
To assess if any of six different formulations of vaccine groups (Group II to Group VI, Group VIII) reduced the incidence of fever >=38.5C (rectal) occurring within three days (day 1-day3) following first vaccination. The analysis was done on the Safety Population.

13 secondary outcomes

Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
Time frame: At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age)
Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
Time frame: At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days
Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
Time frame: After the third and the booster vaccination.
Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose)
Time frame: 12 months (pre-fourth vaccination)
Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose)
Time frame: 1 month after fourth vaccination
Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age)
Time frame: At 13 months
Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster)
Time frame: 1 month after booster
Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination
Time frame: Day 1 through day 7 after second and third vaccination.
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Time frame: Day 1 through day 7 after each vaccination.
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Time frame: Day 1 through day 7 after each vaccination.
Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination
Time frame: Day 1 through day 7 after each vaccination.
Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period.
Time frame: Overall study period.
Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
Time frame: Day 1 through day 7 at 13 months age.

Results and safety

Results posted to the registry on 4 Mar 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
B+OMV (Group I)	188	185
B+½ OMV (Group II)	190	185
B+1/4 OMV (Group III)	192	186
B (Group IV)	188	187
½ (B+OMV) (Group V)	191	188
PH2 B+OMV (Group VI)	188	187
MenC (Group VII)	186	181
Par+B+OMV (Group VIII)	184	183

Primary outcome: Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination

Time frame: At baseline (pre-vaccination) and 30 days after the third vaccination.. Number (95% Confidence Interval). Unit: Percentages of Subjects

Measure	B+OMV (Group I) n = 171	B+½ OMV (Group II) n = 174	B+1/4 OMV (Group III) n = 171	B (Group IV) n = 174	½ (B+OMV) (Group V) n = 172	PH2 B+OMV (Group VI) n = 173	MenC (Group VII) n = 171	Par+B+OMV (Group VIII) n = 169
44/76SLBaseline(N=166,171,168,170,169,168,168,166)	5 (2 to 9)	2 (0 to 5)	4 (1 to 8)	4 (2 to 8)	4 (2 to 8)	4 (2 to 8)	2 (1 to 6)	3 (1 to 7)
44/76-SL > 3rd(N=170,170,166,166,169,167,165,167)	100 (98 to 100)	99 (97 to 100)	99 (97 to 100)	100 (98 to 100)	99 (97 to 100)	99 (96 to 100)	6 (3 to 11)	100 (98 to 100)
5/99-Baseline (N=162,162,161,161,166,166,161,157)	5 (2 to 9)	3 (1 to 7)	6 (3 to 10)	4 (2 to 9)	8 (5 to 14)	4 (2 to 8)	6 (3 to 10)	4 (1 to 8)
5/99 > 3rd (N=165,167,161,166,165,161,159,160)	99 (97 to 100)	100 (98 to 100)	99 (97 to 100)	100 (98 to 100)	100 (98 to 100)	99 (97 to 100)	3 (1 to 7)	99 (97 to 100)
NZ98/254Baseline(N=170,174,171,174,171,173,171,169	1 (0.015 to 3)	0 (0 to 2)	1 (0.015 to 3)	1 (0.015 to 3)	1 (0 to 4)	1 (0 to 4)	2 (0 to 5)	1 (0.015 to 3)
NZ98/254 > 3rd (N=171,172,169,168,172,169,168,168)	78 (71 to 84)	67 (59 to 74)	56 (48 to 64)	1 (0.015 to 3)	62 (54 to 69)	81 (74 to 87)	2 (0 to 5)	74 (67 to 81)

Population analysed: Analysis as per PP population.

Primary outcome: Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination

Time frame: Day 1 to day 3 after first vaccination.. Number. Unit: Subjects

Measure	B+OMV (Group I) n = 182	B+½ OMV (Group II) n = 180	B+1/4 OMV (Group III) n = 186	B (Group IV) n = 184	½ (B+OMV) (Group V) n = 182	PH2 B+OMV (Group VI) n = 180	MenC (Group VII) n = 177	Par+B+OMV (Group VIII) n = 179
Value	94	91	74	24	60	76	21	46

Population analysed: The analysis was done on the Safety Population.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
B+OMV (Group I)	16 of 184 (8.7%)	181 of 184 (98.4%)	Not reported
B+½ OMV (Group II)	20 of 184 (10.9%)	183 of 184 (99.5%)	Not reported
B+1/4 OMV (Group III)	12 of 189 (6.3%)	186 of 189 (98.4%)	Not reported
B (Group IV)	20 of 187 (10.7%)	183 of 187 (97.9%)	Not reported
½ (B+OMV) (Group V)	13 of 187 (7%)	180 of 187 (96.3%)	Not reported
PH2 B+OMV (Group VI)	16 of 185 (8.6%)	180 of 185 (97.3%)	Not reported
MenC (Group VII)	11 of 184 (6%)	175 of 184 (95.1%)	Not reported
Par+B+OMV (Group VIII)	15 of 183 (8.2%)	175 of 183 (95.6%)	Not reported
B+OMV (Group I) Booster Phase	14 of 155 (9%)	151 of 155 (97.4%)	Not reported
B+½ OMV (Group II) Booster Phase	7 of 163 (4.3%)	159 of 163 (97.5%)	Not reported
B+1/4 OMV (Group III) Booster Phase	12 of 169 (7.1%)	162 of 169 (95.9%)	Not reported
B (Group IV) Booster Phase	5 of 169 (3%)	152 of 169 (89.9%)	Not reported
½ (B+OMV) (Group V) Booster Phase	15 of 168 (8.9%)	154 of 168 (91.7%)	Not reported
PH2 B+OMV (Group VI) Booster Phase	9 of 165 (5.5%)	156 of 165 (94.5%)	Not reported
MenC (Group VII) Booster Phase	9 of 165 (5.5%)	155 of 165 (93.9%)	Not reported
Par+B+OMV (Group VIII) Booster Phase	14 of 161 (8.7%)	150 of 161 (93.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35257644Viviani V, Biolchi A, Pizza M. Synergistic activity of antibodies in the multicomponent 4CMenB vaccine. Expert Rev Vaccines. 2022 May;21(5):645-658. doi: 10.1080/14760584.2022.2050697. Epub 2022 Mar 14.
Derived from this study: PubMed 25424810Esposito S, Prymula R, Zuccotti GV, Xie F, Barone M, Dull PM, Toneatto D. A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in infants (II). Hum Vaccin Immunother. 2014;10(7):2005-14. doi: 10.4161/hv.29218.

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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.

38 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 2 inclusion and 17 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 7 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 38 sites in Czechia, Hungary, Italy, Chile, Argentina. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Mar 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 Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination (time frame: At baseline (pre-vaccination) and 30 days 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 NCT00937521, 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 7 Apr 2015.