Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules

PHASE2CompletedINTERVENTIONAL
Enrollment

1,885

Participants

Timeline

Start Date

August 31, 2008

Primary Completion Date

July 31, 2010

Study Completion Date

July 31, 2010

Conditions
Meningococcal Infections
Interventions
BIOLOGICAL

rMenB+OMV NZ

BIOLOGICAL

combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine

BIOLOGICAL

Pneumococcal vaccine

Trial Locations (60)

1090

Study Investigational Site Nr. 60, Brussels

1200

Novartis Investigational Site Nr. 57, Brussels

2018

Novartis Investigational Site Nr. 55, Antwerp

2650

Novartis Investigational Site Nr. 59, Edegem

3500

Novartis Investigational Site Nr. 56, Hasselt

5000

Novartis Investigational Site Nr. 58, Namur

12006

Novartis Investigational Site Nr. 10, Castellon

12550

Novartis Investigational Site Nr. 11, Almassora

12600

Novartis Investigational Site Nr. 12, Vall D'Uixo

13125

Novartis Investigational Site Nr. 70, Berlin

15706

Novartis Investigational Site Nr. 46, Santiago de Compostela

20122

Novartis Investigational Site Nr. 5, Milan

20157

Novartis Investigational Site Nr. 52, Milan

22415

Novartis Investigational Site Nr. 72, Hamburg

23617

Novartis Investigational Site Nr. 87, Stockelsdorf

25524

Novartis Investigational Site Nr. 88, Itzenhoe

Novartis Investigational Site Nr. 89, Itzenhoe

27568

Novartis Investigational Site Nr. 71, Bremerhaven

28100

Novartis Investigational Site Nr. 6, Novara

33006

Novartis Investigational Site Nr. 49, Oviedo

33617

Novartis Investigational Site Nr. 85, Bielefeld

34225

Novartis Investigational Site Nr. 73, Baunatal

34414

Novartis Investigational Site Nr. 83, Warburg

35100

Novartis Investigational Site Nr. 9, Padua

36204

Novartis Investigational Site Nr. 48, Vigo Pontevedra

39164

Novartis Investigational Site Nr. 86, Wanzleben

41236

Novartis Investigational Site Nr. 78, Mönchengladbach

42579

Novartis Investigational Site Nr. 79, Heiligenhaus

44866

Novartis Investigational Site Nr. 81, Bochum

46011

Novartis Investigational Site Nr. 17, Valencia

46017

Novartis Investigational Site Nr. 24, Valencia

46021

Novartis Investigational Site Nr. 15, Valencia

46022

Novartis Investigational Site Nr. 18, Valencia

Novartis Investigational Site Nr. 19, Valencia

46024

Novartis Investigational Site Nr. 16, Valencia

46183

Novartis Investigational Site Nr. 21, L'Eliana

46200

Novartis Investigational Site Nr. 23, Valencia

46470

Novartis Investigational Site Nr. 25, Catarroja

46500

Novartis Investigational Site 14, Sagunto

47533

Novartis Investigational Site Nr. 80, Kleve Materborn

48163

Novartis Investigational Site Nr. 82, Münster

49565

Novartis Investigational Site Nr. 75, Bramsche

50139

Novartis Investigational Site Nr. 7, Florence

55131

Novartis Investigational Site Nr. 61, Mainz

63739

Novartis Investigational Site Nr. 69, Aschaffenburg

71720

Novartis Investigational Site Nr. 64, Oberstenfeld

73642

Novartis Investigational Site Nr. 66, Welzheim

75015

Novartis Investigational Site Nr. 65, Bretten

76889

Novartis Investigational Site Nr. 67, Schweigen

77694

Novartis Investigational Site Nr. 62, Kehl

88348

Novartis Investigational Site Nr. 68, Bad Saulgau

99086

Novartis Investigational Site Nr. 90, Erfurt

549 41

Novartis Investigational Site Nr. 95, Červený Kostelec

500 00

Novartis Investigational Site Nr. 93, Hradec Králové

530 01

Novartis Investigational Site Nr. 94, Pardubice

377 01

Novartis Investigational Site Nr. 96, Jindřichův Hradec

SW17 0RE

Novartis Investigational Site Nr. 2, London

OX3 7LE

Novartis Investigational Site Nr. 1, Oxford

BS8 1TH

Novartis Investigational Site 3, Bristol

EX2 5DW

Novartis Investigational Site Nr. 4, Exeter

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY