One Year Antibody Persistence After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting From 12 Months of Age and Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age

PHASE3CompletedINTERVENTIONAL
Enrollment

508

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

November 30, 2010

Study Completion Date

September 30, 2011

Conditions
Meningococcal Disease
Interventions
BIOLOGICAL

rMenB+OMV NZ

Subjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects). In addition, one group of naïve age-matched subjects will be recruited at the same study sites. Subjects who had received 4 doses of rMenB+OMV NZ will have one visit including one blood draw. Subjects who had received two catch-up doses in V72P13E1 will receive a third dose boost and will have 3 blood samples drawn. Naïve subjects will receive two catch-up doses and have 3 blood samples drawn.

Trial Locations (19)

33520

University of Tampere Medical School, Vaccine Research Center Tampere, Biokatu 10

Unknown

amostatná ordinace praktického lékaře pro děti a dorost Jindřichův Hradec, Hradec

Dětské oddělení nemocnice Náchod, Náchod

Dětské oddělení nemocnice Pardubice, Pardubice

Espoo Vaccine Research Clinic,, Espoo

Helsinki East, Vaccine Research Clinic,, Helsinki

Helsinki South, Vaccine Research Clinic,, Helsinki

Järvenpää, Vaccine Research Clinic, Järvenpää

Kokkola Vaccine Research Clinic, Kokkola

Kotka Vaccine Research Clinic, Kotka

Kuopio Vaccine Research Clinic, Kuopio

Lahti Vaccine Research Clinic, Lahti

Oulu Vaccine Research Clinic, Oulu

Pori Vaccine Research Clinic, Pori

Seinäjoki Vaccine Research Clinic, Seinäjoki

Tampere Vaccine Research Clinic, Tampere

Turku Vaccine Research Clinic, Turku

Vantaa East, Vaccine Research Clinic, Vantaa

Vantaa West, Vaccine Research Clinic, Vantaa

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY