Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1

PHASE3CompletedINTERVENTIONAL
Enrollment

805

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

September 30, 2013

Study Completion Date

October 31, 2013

Conditions
Meningococcal DiseaseMeningococcal Meningitis
Interventions
BIOLOGICAL

1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine

0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose

BIOLOGICAL

2 doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine

0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, two doses, two months apart

Trial Locations (29)

15706

Hospital Clinico Universitario de Santiago de Compostela, Santiago de Compostela A Coruña

20122

IRCCS Cà Granda, Milan

28100

Ospedale Maggiore della Carita, Novara

35128

Dip Pediatria AO Padova, Padua

36204

Complexo Hospitalario Xeral Cies, Vigo Pontevedra

37701

Ordinace praktickeho lekare pro deti a dorost, Jindřichův Hradec

Ordinace praktickeho lekare pro deti a dorost, Jindřichův Hradec

Ordinace praktickeho lekare pro deti a dorost, Jindřichův Hradec

46017

Hospital Universitario Dr. Peset, Valencia

50001

Fakulta vojenskeho zdravotnictvi UO, Hradec Králové

50002

Ordinace praktickeho lekare pro deti a dorost, Hradec Králové

50004

Ordinace praktickeho lekare pro deti a dorost, Hradec Králové

50139

Universita di Firenze -Pediatria, Florence

50351

Ordinace praktickeho lekare pro deti a dorost, Chlumec nad Cidlinou

53002

Ordinace praktickeho lekare pro deti a dorost, Pardubice

53012

Ordinace praktickeho lekare pro deti a dorost, Pardubice

53304

Ordinace praktickeho lekare pro deti a dorost, Sezemice

53401

Ordinace praktickeho lekare pro deti a dorost, Holice

54701

Nemocnice Náchod, Náchod

54931

Ordinace praktickeho lekare pro deti a dorost, Hronov

Ordinace praktickeho lekare pro deti a dorost, Hronov

55101

Ordinace praktickeho lekare pro deti a dorost, Jaroměř

Ordinace praktickeho lekare pro deti a dorost, Jaroměř

55203

Ordinace praktickeho lekare pro deti a dorost, Česká Skalice

46020/46001

Centro Superior de Investigacion en Salud Publica/Clinica Universitaria San Vicente Martir, Valencia

OX3 7LJ

Oxford Vaccine Group - Centre for Clinical Vaccinology and Tropical Medicine Churchill Hospital, Oxford

BS1 3NU

North Bristol NHS Trust, Bristol

EX2 5DW

Royal Devon and Exeter NHS Foundation Trust, Exeter

SW17 0RE

St Georges Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY

NCT01717638 - Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1 | Biotech Hunter | Biotech Hunter