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

NCT ID: NCT00937521

Last Updated: 2015-04-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1507 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-02-29

Brief Summary

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

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Detailed Description

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Conditions

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Meningococcal Meningitis Meningococcal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Vaccine candidate formulation I

Group Type OTHER

Meningococcal B vaccine

Intervention Type BIOLOGICAL

Vaccine candidate formulation I

2

Vaccine candidate formulation II

Group Type OTHER

Meningococcal B vaccine

Intervention Type BIOLOGICAL

Vaccine candidate formulation II

3

Vaccine candidate formulation III

Group Type OTHER

Meningococcal B vaccine

Intervention Type BIOLOGICAL

Vaccine candidate formulation III

4

Vaccine candidate formulation IV

Group Type OTHER

Meningococcal B vaccine

Intervention Type BIOLOGICAL

Vaccine candidate formulation IV

5

Vaccine candidate formulation V

Group Type OTHER

Meningococcal B vaccine

Intervention Type BIOLOGICAL

Vaccine candidate formulation V

6

Vaccine candidate formulation VI

Group Type OTHER

Meningococcal B vaccine

Intervention Type BIOLOGICAL

Vaccine candidate formulation VI

7

Control

Group Type OTHER

Control

Intervention Type BIOLOGICAL

Control

8

Vaccine candidate formulation I with antipyretic

Group Type OTHER

Meningococcal B vaccine with antipyretic

Intervention Type BIOLOGICAL

Vaccine candidate formulation I with antipyretic

Interventions

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Meningococcal B vaccine

Vaccine candidate formulation I

Intervention Type BIOLOGICAL

Meningococcal B vaccine

Vaccine candidate formulation II

Intervention Type BIOLOGICAL

Meningococcal B vaccine

Vaccine candidate formulation III

Intervention Type BIOLOGICAL

Meningococcal B vaccine

Vaccine candidate formulation IV

Intervention Type BIOLOGICAL

Meningococcal B vaccine

Vaccine candidate formulation V

Intervention Type BIOLOGICAL

Meningococcal B vaccine

Vaccine candidate formulation VI

Intervention Type BIOLOGICAL

Control

Control

Intervention Type BIOLOGICAL

Meningococcal B vaccine with antipyretic

Vaccine candidate formulation I with antipyretic

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

55 Days

Maximum Eligible Age

89 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Privado de Córdoba CMC SA

Naciones Unidas 346, Córdoba Province, Argentina

Site Status

Universidad de Chile, Av Independencia 1027

Comuna de Independencia, Santiago Metropolitan, Chile

Site Status

Consultorio Manuel Bustos

Lo Cruzat 486, Quilicura, Santiago Metropolitan, Chile

Site Status

Samostatna ordinace praktickeho lekare pro deti a dorost

O. Kubina 17, Boskovice, Czechia

Site Status

Samostatna ordinace praktickeho lekare pro deti a dorost

Neklez 3, Brno, Czechia

Site Status

Samostatna ordinace praktickeho lekare pro deti a dorost

Pernštýnská 127/l, Chlumec Nad Cidlinou, Czechia

Site Status

Zdravotní středisko

Vaclavska 4186, Chomutov, Czechia

Site Status

Nemocnice Decin, Detske oddělení

U Nemocnice 1, Děčín, Czechia

Site Status

Fakulta vojenskeho zdravotnictvi UO

Trebešská 1575, Hradec Králové, Czechia

Site Status

Samostatna ordinace praktickeho lekare pro deti a dorost

Masarykova 389, Humpolec, Czechia

Site Status

Samostatna ordinace praktickeho lekare pro deti a dorost

Ruských Legii 352, Jindřichův Hradec, Czechia

Site Status

Samostatna ordinace praktickeho lekare pro deti a dorost

Hrnčířská 1401, Lipník Nad Bečvou, Czechia

Site Status

Oblastni nemocnice Nachod, Destske oddělení

Purkyňova 446, Náchod, Czechia

Site Status

Samostatna ordinace praktickeho lekare pro deti a dorost

U Lékárny 306, Odolena Voda, Czechia

Site Status

Prakticky lekar pro deti a dorost

Dvouletky 54, Ostrava, Czechia

Site Status

KHS Ostrava, Protiepidemické oddělení

Na Bělidle 7, Ostrava, Czechia

Site Status

Nemocnice Pardubice, Destske odděleni

Kyjevská 44, Pardubice, Czechia

Site Status

Fakultni nemocnice Bory

E. Beneše 13, Plzeň, Czechia

Site Status

Samostatna ordinace praktickeho lekare pro deti a dorost

Chrudimska 2a, Praha 3, Czechia

Site Status

Samostatna ordinace praktickeho lekare pro deti a dorost

Kladenská 53, Praha 6, Czechia

Site Status

Samostatna ordinace praktickeho lekare pro deti a dorost

Velka Michalska 22, Znojmo, Czechia

Site Status

Házi Gyermekorvosi szolgálat

Honvéd U.2., Bordány, Hungary

Site Status

Medszolg 2000 Bt, 6723, Szeged, Dandár u.4

Ányos U.4., Budapest, Hungary

Site Status

Erzsébet Kórház Gyermekosztály

Hódmezővásárhely, Dr. Imre József U.2., Hungary

Site Status

Baby Box Bt,, 6724, Szeged, Kossuth Lajos sgt.109

Szeged, Kossuth Lajos Sgt.109, Hungary

Site Status

Dr. Bán Mariann és Társa Bt.

Kando Kalman U.1, Miskolc, Hungary

Site Status

Futurnest Kft

Selyemrét U.1., Miskolc, Hungary

Site Status

Ped-Med Kft. , 3434 Mályi, Fő u.12.

Fő U.12., Mályi, Hungary

Site Status

S.K. Sipka és Kovács Eü. Bt.

Csongrádi Sgt. 63., Szeged, Hungary

Site Status

Oszila Kft. 6723, Szeged, Debreceni u.10-14.

Debreceni U.10-14., Szeged, Hungary

Site Status

Győriné dr. Bari Eszter egyéni vállalkozó

Csongrád, Szentháromság Tér 10, Hungary

Site Status

Vas Megyei Markusovszky Kórház, Gyermekosztály

Markusovszky U. 1-3, Szombathely, Hungary

Site Status

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, Italy

Site Status

Dipartimento di Pediatria dell'Università degli Studi di Firenze

Viale Pieraccini N. 24, Firenze, Italy

Site Status

Università degli Studi di Messina, Pad. NI - A.O.U. Policlinico G.Martino

Via Consolare Valeria, 1, Messina, Italy

Site Status

Fondazione IRCCS dell'Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena di Milano

Via Commenda, 9, Milano, Italy

Site Status

Pediatria dell'Ospedale Sacco di Milano

Via G.B.Grossi 74, Milano, Italy

Site Status

Dipartimento di Pediatria Azienda Ospedaliera di Padova

Via Giustiniani, 3, Padova, Italy

Site Status

Countries

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Argentina Chile Czechia Hungary Italy

References

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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.

Reference Type DERIVED
PMID: 35257644 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25424810 (View on PubMed)

Other Identifiers

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2009-010106-11

Identifier Type: -

Identifier Source: secondary_id

V72P16

Identifier Type: -

Identifier Source: org_study_id

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