Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers

PHASE3CompletedINTERVENTIONAL
Enrollment

2,249

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

August 31, 2010

Study Completion Date

August 31, 2010

Conditions
Meningococcal Disease
Interventions
BIOLOGICAL

1a - rMenB+OMV NZ and routine vaccines

One dose of rMenB vaccine and routine vaccine at study month 12.

BIOLOGICAL

1b - rMenB+OMV NZ and routine vaccines

One dose of rMenB vaccine at study month 12 and routine vaccine at study month 13.

BIOLOGICAL

2a - Routine and rMenB+OMV NZ vaccines

One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.

BIOLOGICAL

2b - rMenB+OMV NZ and routine vaccines

Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.

BIOLOGICAL

3a - rMenB+OMV NZ and routine vaccines

One dose of rMenB vaccine and one dose of routine vaccine at study month 12.

BIOLOGICAL

3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations

One dose of rMenB vaccine at study month 12 and one dose of routine vaccine study month 13.

BIOLOGICAL

4a- rMenB+OMV NZ and routine vaccines

One dose of rMenB vaccine and one dose of routine vaccine at study month 12.

BIOLOGICAL

4b - rMenB+OMV NZ and routine vaccines

One dose of rMenB vaccine and one dose of routine vaccine at study month 12.

Trial Locations (59)

1230

Sommer, Vienna

2491

Prieler, Neufeld A.d. Leitha

4560

Häckel, Kirchdorf

4600

Angermayr, Wels

5020

Maurer, Salzburg

6060

Grässl, Hall in Tirol

7000

Altenburger, Eisenstadt

15140

Site 47, Lahti

16132

Dipartimento di Scienze della Salute, Genova

20122

Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia, Milan

20157

Pediatria dell' Ospedale Sacco, Milan

20520

Site 53, Turku

28100

Site 50, Pori

Ospedale Maggiore di Novara, Novara

32339

Site 92, Espelkamp

32457

Site 81, Porta Westfalica

32756

Site 99, Detmold

33100

Site 52, Tampere

36037

Site 64, Fulda

48600

Site 45, Kotka

60100

Site 51, Seinäjoki

67100

Site 35, Kokkola

70100

Site 46, Kuopio

71672

Site 57, Marbach A. N.

71701

Site 65, Schwieberdingen

74100

ASL/TA, Taranto

74348

Site 58, Lauffen am Neckar

80337

Site 80, München

81241

Site 83, München

81377

Site 97, München

81475

Site 96, München

81737

Site 91, Műnchen

82362

Site 94, Weilheim

85354

Site 95, Freising

90220

Site 49, Oulu

680 01

Site 27, Boskovice

628 00

Site 19, Brno

430 03

Site 22, Chomutov

580 22

Site 12, Havlíčkův Brod

500 01

Fakulta vojenskeho zdravotnictví, Hradec Králové

753 01

Site 28, Hranice I-mesto

396 01

Site 13, Humpolec

272 00

Site 25, Kladno

280 02

Site 21, Kolín

460 15

Site 10, Liberec

412 01

Site 24, Litoměřice

702 00

Site 17, Ostrava

708 68

Site 18, Ostrava-Poruba

305 99

Site 16, Pilsen

408 01

Site 26, Rumburk

400 01

Site 23, Ústí nad Labem

02100

Site 30, Espoo

00100

Site 31, Helsinki

00930

Site 32, Helsinki

04400

Site 34, Järvenpää

01300

Site 33, Vantaa

01600

Site 48, Vantaa

07100

Istituto di Igiene e Medicina Preventiva - Università degli Studi di Sassari, Sassari

Unknown

Universita degli Studi di Messina, Policlinico G. Martino, Messina

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY

NCT00847145 - Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers | Biotech Hunter | Biotech Hunter