Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

1,588

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

August 31, 2011

Study Completion Date

January 31, 2012

Conditions
Meningococcal DiseaseMeningococcal Meningitis
Interventions
BIOLOGICAL

rMenB+OMV NZ with routine vaccinations

rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 12 months of age

BIOLOGICAL

rMenB+OMV NZ with routine vaccinations

rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 18 months of age

BIOLOGICAL

rMenB+OMV NZ

rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 12 months of age

BIOLOGICAL

rMenB+OMV NZ

rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 18 months of age

BIOLOGICAL

rMenB+OMV NZ with routine vaccinations

rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 12 months of age

BIOLOGICAL

rMenB+OMV NZ with routine vaccinations

rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 18 months of age

BIOLOGICAL

two doses of rMenB+OMV NZ

two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age.

BIOLOGICAL

rMenB+OMV NZ with routine vaccinations

rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 24 months of age

BIOLOGICAL

two doses of rMenB+OMV NZ

two catch-up doses of rMenB+OMV NZ at 18 and 20 months of age

BIOLOGICAL

rMenB+OMV NZ

rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 24 months of age

BIOLOGICAL

two doses of rMenB+OMV NZ

two catch-up doses of rMenB+OMV NZ at 24 and 26 months of age

BIOLOGICAL

rMenB+OMV NZ with routine vaccinations

rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 12 (Group 3a), 18 (Group 3b) or 24 (Group 3c) months of age

Trial Locations (72)

Unknown

Avenue Albert 1er 185, 5000 Namur

Avenue Hippocrate 10, 1200 Brussels

Laarbeeklaan 101, 1090 Brussels

Lindendreef 1, 2020 Antwerpen

Sint Vincentiusstraat 20, 2018 Antwerpen

Stadsomvaart 11, 3500 Hasselt

Wilrijkstraat 10, 2650 Edegem

Kyjevska 44, 532 03 Pardubice

Ruskych Legii 352, 377 01 Jindrichuv Hradec

Trebesska 1575, 500 01 Hradec Kralove

Ahrensböker Str. 11, 23617 Stockelsdorf

Am Alten Hafen 117, 27568 Bremerhaven

Ammertalweg 7, 99086 Erfurt

Anne Frank Str.27, 75015 Bretten

Bucher Chaussee 1-3, 13125 Berlin

Christian-Bauer-Str.5, 73642 Welzheim

Deckertstr. 53, 33645 Bielefeld

Dingbängerweg 69, 48163 Münster

Elisenstr. 28, 63739 Aschaffenburg

Gartenstr. 3,76889 Schweigen

Großbottwarer Str. 47, 71720 Oberstenfeld

Hanseatenplatz 1, 25524 Itzehoe

Hauptstr. 165, 42579 Heiligenhaus

Hauptstr. 240, 77694 Kehl

Hauptstr. 46, 37083 Göttingen

Josef-Sugg-Str. 5, 88348 Bad Saulgau

Kapellenstraße 27, 47533 Kleve-Materborn

Kleinenbroicher Str. 68, 41352 Korschenbroich

Kuhtrift 8a, 34414 Warburg

Langenbeckstraße 1, 55101 Mainz

Lindenpromenade 34b, 39164 Wanzleben

Lindenstr. 9, 25524 Itzehoe

Marienstraße 2, 44866 Bochum

Maschstr. 8a, 49565 Bramsche

Mose-Stern-Str. 28, 41236 Mönchengladbach

Ostlandstr. 10, 32339 Espelkamp

Poststr. 10, 34225 Baunatal

Tangstedter Landstr 77, 22415 Hamburg

Wilhelmshöher Allee 109, 34121 Kassel

Würzburger Str. 1, 97941 Tauberbischofsheim

C.so Mazzini 18, 28100 Novar

Current Address: Via Luca Giordano N. 13, 50132 Firenze

Piazza Ospedale 10, 20900 Lodi

Via Commenda 9, 20122, Milano

Via Consolare Valeria 1, 98125 Messina

Via G.B.Grossi 74, 20157 Milano

Via Giustiniani,3, 35128 Padova

Via Pastore 1,16132 Genova

Via Siracusa, 45, 90143 Palermo

Viale Pieraccini N. 24 50139 Firenze

Avda. Rambleta, S/n Catarroja Valencia

C/ Tossal Del Rei Nº 7 Castellón de La Plana Castellón

Catarroja Esquina Ministro Serrano. Paiporta Valencia

Celestino Villamil, S/n Oviedo

Ctra. Anfondeguilla, S/n Vall Duixo Castellón

Isabel de Villena,2 Pabellón Valencia

Médico Fernando Moray de La Horra, 2 Acceso Y9 Valencia

Molí S/n Puçol Valencia

Pedro S/n Almazora Castellón

Pizarro, 22 Vigo Pontevedra

Plaza Blasco Ibañez, 4 Sagunto Valencia

Plaza Segovia S/n Valencia

República Argentina Nº 8, Valencia

Rosales, 23 La Eliana Valencia

Serreria,73 Valencia

Travesía Da Choupana, S/n Santiago de Compostela A Coruña

549 41

Červený Kostelec

BS1 3NU

University Hospitals Bristol, NHS Foundation Trust, Trust Headquarters, Marlborough Street

EX2 5DW

South West Medicines for Children Research Network, Child Health Building, Royal Devon and Exeter NHS Foundation Trust, Barrack Road

SW17 0RE

St. George's University of London, Cranmer Terrace

OX3 7LJ

Oxford Vaccines Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road, Headington

Centre for Clinical Vaccinology, Oxford

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Novartis Vaccines

INDUSTRY