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

PHASE2CompletedINTERVENTIONAL
Enrollment

1,507

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

November 30, 2010

Study Completion Date

February 29, 2012

Conditions
Meningococcal MeningitisMeningococcal Infections
Interventions
BIOLOGICAL

Meningococcal B vaccine

Vaccine candidate formulation I

BIOLOGICAL

Meningococcal B vaccine

Vaccine candidate formulation II

BIOLOGICAL

Meningococcal B vaccine

Vaccine candidate formulation III

BIOLOGICAL

Meningococcal B vaccine

Vaccine candidate formulation IV

BIOLOGICAL

Meningococcal B vaccine

Vaccine candidate formulation V

BIOLOGICAL

Meningococcal B vaccine

Vaccine candidate formulation VI

BIOLOGICAL

Control

Control

BIOLOGICAL

Meningococcal B vaccine with antipyretic

Vaccine candidate formulation I with antipyretic

Trial Locations (38)

1031

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

3434

Ped-Med Kft. , 3434 Mályi, Fő u.12., Fő U.12.

3527

Futurnest Kft, Selyemrét U.1.

3534

Dr. Bán Mariann és Társa Bt., Kando Kalman U.1

6723

S.K. Sipka és Kovács Eü. Bt., Csongrádi Sgt. 63.

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

6795

Házi Gyermekorvosi szolgálat, Honvéd U.2.

9700

Vas Megyei Markusovszky Kórház, Gyermekosztály, Markusovszky U. 1-3

20122

Fondazione IRCCS dell'Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena di Milano, Via Commenda, 9

20157

Pediatria dell'Ospedale Sacco di Milano, Via G.B.Grossi 74

25125

"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

35128

Dipartimento di Pediatria Azienda Ospedaliera di Padova, Via Giustiniani, 3

50001

Fakulta vojenskeho zdravotnictvi UO, Trebešská 1575

50139

Dipartimento di Pediatria dell'Università degli Studi di Firenze, Viale Pieraccini N. 24

98125

Università degli Studi di Messina, Pad. NI - A.O.U. Policlinico G.Martino, Via Consolare Valeria, 1

X5016KHE

Hospital Privado de Córdoba CMC SA, Naciones Unidas 346

Unknown

Universidad de Chile, Av Independencia 1027, Comuna de Independencia

Consultorio Manuel Bustos, Lo Cruzat 486, Quilicura

Erzsébet Kórház Gyermekosztály, Hódmezővásárhely

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

Győriné dr. Bari Eszter egyéni vállalkozó, Csongrád

680 01

Samostatna ordinace praktickeho lekare pro deti a dorost, O. Kubina 17

628 00

Samostatna ordinace praktickeho lekare pro deti a dorost, Neklez 3

503 51

Samostatna ordinace praktickeho lekare pro deti a dorost, Pernštýnská 127/l

430 03

Zdravotní středisko, Vaclavska 4186

405 01

Nemocnice Decin, Detske oddělení, U Nemocnice 1

396 01

Samostatna ordinace praktickeho lekare pro deti a dorost, Masarykova 389

377 01

Samostatna ordinace praktickeho lekare pro deti a dorost, Ruských Legii 352

751 31

Samostatna ordinace praktickeho lekare pro deti a dorost, Hrnčířská 1401

547 01

Oblastni nemocnice Nachod, Destske oddělení, Purkyňova 446

250 70

Samostatna ordinace praktickeho lekare pro deti a dorost, U Lékárny 306

700 30

Prakticky lekar pro deti a dorost, Dvouletky 54

702 00

KHS Ostrava, Protiepidemické oddělení, Na Bělidle 7

532 03

Nemocnice Pardubice, Destske odděleni, Kyjevská 44

305 99

Fakultni nemocnice Bory, E. Beneše 13

130 00

Samostatna ordinace praktickeho lekare pro deti a dorost, Chrudimska 2a

160 00

Samostatna ordinace praktickeho lekare pro deti a dorost, Kladenská 53

669 00

Samostatna ordinace praktickeho lekare pro deti a dorost, Velka Michalska 22

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY

NCT00937521 - Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants | Biotech Hunter | Biotech Hunter