NCT00657709 - Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants | Biotech Hunter

Enrollment

3,630

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

January 31, 2010

Study Completion Date

January 31, 2010

Conditions

Serogroup B Meningococcal Meningitis

Interventions

BIOLOGICAL

Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)

One dose of rMenB Lot concomitantly with the routinely administered infant vaccines

BIOLOGICAL

Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)

One dose of rMenB concomitantly with the routinely administered infant vaccines

BIOLOGICAL

Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)

One dose of rMenB concomitantly with the routinely administered infant vaccines

BIOLOGICAL

Infanrix Hexa

Routine vaccination

BIOLOGICAL

Menjugate

One dose of the routinely administered infant vaccines + MenC vaccine

BIOLOGICAL

Prevenar

Routine vaccination

Trial Locations (66)

1230

Sommer, Vienna

2491

Prieler, Neufeld A.d. Leitha

4560

Häckel, Kirchdorf

4600

Angermayr, Wels

5020

Maurer, Salzburg

6060

Grässl, Hall in Tirol

15140

Site 47, Lahti

16000

Site 5, Prague

16132

Dipartimento di Scienze della Salute, Genova

19000

Site 6, Prague

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 della Carita'-Clinica Pediatrica, 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

54941

Site11, Červený Kostelec

60100

Site 51, Seinäjoki

67100

Site 35, Kokkola

70211

Site 46, Kuopio

71701

Site 65, Schwieberdingen

74100

ASL/TA, Taranto

74348

Site 58, Lauffen am Neckar

Site 57, Marbach A. N.

81377

Site 97, München

81475

Site 96, München

81737

Site 91, Műnchen

82362

Site 94, Weilheim

85354

Site 95, Freising

90220

Site 49, Oulu

98122

Università degli Studi di Messina - Pad. NI - A.O.U. Policlinico G. Martino, Messina

680 01

Site 27, Boskovice

628 00

Site 19, Brno

430 03

Site 22, Chomutov

405 01

Site 14, Děčín

580 22

Site 12, Havlíčkův Brod

500 01

Site 8, Hradec Králové

500 05

Site 9, Hradec Králové

753 01

Site 28, Hranice I-mesto

396 01

Site 13, Humpolec

377 01

Site 15, Jindřichův Hradec

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

532 03

Site 7, Pardubice

305 99

Site 16, Pilsen

130 00

Site 2, Prague

140 00

Site 3, Prague

408 01

Site 26, Rumburk

400 01

Site 23, Ústí nad Labem

669 00

Site 20, Znojmo

02230

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