A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years

PHASE3CompletedINTERVENTIONAL
Enrollment

1,409

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

January 31, 2014

Study Completion Date

December 31, 2014

Conditions
Meningococcal DiseaseMeningococcal Meningitis
Interventions
BIOLOGICAL

rMenB + OMV NZ vaccine

3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)

BIOLOGICAL

rMenB + OMV NZ vaccine

2 doses (3.5, 5 months of age) plus booster (11 months of age)

BIOLOGICAL

rMenB + OMV NZ vaccine

2 doses (6, 8 months of age) plus booster (11 months of age)

BIOLOGICAL

rMenB + OMV NZ vaccine

2 doses 2 months apart

BIOLOGICAL

Meningococcal C oligosaccharide conjugated vaccine

Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine

BIOLOGICAL

Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.

Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.

BIOLOGICAL

rMenB + OMV NZ vaccine

Schedule 3, 5, 12 rMenB + OMV vaccine

BIOLOGICAL

rMenB + OMV NZ vaccine

Schedule 13,15 rMenB + OMV vaccine

Trial Locations (26)

3434

Site 32 - Praxis Dr Eleonora Konya, Fo Utca 12

3527

Site 30 - General Practice Dr Simko, Selyemret U. 1.

3534

Site 31 - General Practice Dr Olga Fekete, Kando Kalman Utca 1

4025

Site 34 - General Pediatric Practice Somorjai, Bajcsi Ut 32

4400

Site 33 - General Pediatric Practice Ujhelyi, Szent Istvan U 10

6640

Site 42 - Praxis Dr Eszter Bari, Szentharomsag Ter 10

6723

Site 35 - Praxis Dr Eva Kovacs, Csongradi Sgt 63

Site 36 - General Practice Dr Edit Oszlacs, Debreceni Utca 10-14

6795

Site 37 - Praxis Dr Julianna Kovacs, Honved Utca 2

15706

Site 10, Santiago de Compostela

28041

Site 17, Madrid

28935

Site 18, Madrid

32005

Site 11, Ourense

36002

Site 13, Pontevedra

41014

Site 14, Seville

50070-550

Site 55 - Instituto de Medicina Integral Prof. Fernando Figueira (IMIP), Rua Dos Coelhos, 300 - Boa Vista

40420-000

Site 54- Associação Obras Sociais Irmã Dulce, Avenida Bonfim, nº 161, Largo de Roma

04038002

Site 53 - CRIE UNIFESP, Rua Borges Lagoa 770

04020-060

Site 50 - Associacao Fundo de Incentivo a Psicofarmacologia, Rua Marselhesa 500 Vila Clementino

Unknown

Site 40 - General Pediatric Practice Hacsek, Poth Iren U 80

Site 80 - Hospital Nacional docente Madre Nino San Bartolome, Av Alfonso Ugarte

Site 82 - Investigaciones Medicas en Salud INMENSA, Jr Jose de La Torre Ugarte Lince

Site 81 - Via Libre, Jr Paraguay Cercado de Lima

04007

Site 15, Almería

04120

Site 16, Almería

08195

Site 20, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY

NCT01339923 - A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years | Biotech Hunter | Biotech Hunter