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

A Phase 2b, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis Meningococcal B Recombinant Vaccine Administered at 12, 18 or 24 Months of Age in Subjects Who Previously Received a Three-Dose Primary Series of the Novartis Meningococcal B Recombinant Vaccine as Infants in Study V72P12

This extension study V72P12E1 will investigate the safety, tolerability and immunogenicity of a fourth (booster) dose of rMenB+OMV NZ at 12, 18 and 24 months of age in subjects previously primed with rMenB+OMV NZ according to two different three-dose immunization schedules in infancy (2, 4 and 6 or 2, 3 and 4 months of age in the parent study V72P12). The study will also explore the bactericidal antibody persistence at 12, 18 and 24 months of age, following the two different immunization schedules, in order to identify the optimal timing for boosting. Two catch-up rMenB+OMV NZ doses will be given to unprimed, naïve toddlers at 12 (subjects enrolled in the control group of V72P12), 18 and 24 months of age (two new cohort of subjects enrolled). These subjects will generate data for assessing the safety and immunogenicity of a two-dose catch-up regimen at these ages, but will also serve as controls for a descriptive comparison of antibody persistence and booster responses for the other groups.

Study Overview

• Status: Completed
• Conditions: Meningococcal Disease; Meningococcal Meningitis
• Intervention / Treatment: Biological: rMenB+OMV NZ with routine vaccinations; Biological: rMenB+OMV NZ with routine vaccinations; Biological: rMenB+OMV NZ with routine vaccinations; Biological: rMenB+OMV NZ with routine vaccinations; Biological: rMenB+OMV NZ with routine vaccinations; Biological: rMenB+OMV NZ with routine vaccinations; Biological: rMenB+OMV NZ; Biological: rMenB+OMV NZ; Biological: rMenB+OMV NZ; Biological: two doses of rMenB+OMV NZ; Biological: two doses of rMenB+OMV NZ; Biological: two doses of rMenB+OMV NZ

• Study Type: Interventional
• Enrollment (Actual): 1588
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Avenue Albert 1er 185, 5000 Namur, Belgium
  • Avenue Hippocrate 10, 1200 Brussels, Belgium
  • Laarbeeklaan 101, 1090 Brussels, Belgium
  • Lindendreef 1, 2020 Antwerpen, Belgium
  • Sint Vincentiusstraat 20, 2018 Antwerpen, Belgium
  • Stadsomvaart 11, 3500 Hasselt, Belgium
  • Wilrijkstraat 10, 2650 Edegem, Belgium
• Czechia
  • Cerveny Kostelec, Czechia, 549 41
  • Kyjevska 44, 532 03 Pardubice, Czechia
  • Ruskych legii 352, 377 01 Jindrichuv Hradec, Czechia
  • Trebesska 1575, 500 01 Hradec Kralove, Czechia
• Germany
  • Ahrensböker Str. 11, 23617 Stockelsdorf, Germany
  • Am Alten Hafen 117, 27568 Bremerhaven, Germany
  • Ammertalweg 7, 99086 Erfurt, Germany
  • Anne Frank Str.27, 75015 Bretten, Germany
  • Bucher Chaussee 1-3, 13125 Berlin, Germany
  • Christian-Bauer-Str.5, 73642 Welzheim, Germany
  • Deckertstr. 53, 33645 Bielefeld, Germany
  • Dingbängerweg 69, 48163 Münster, Germany
  • Elisenstr. 28, 63739 Aschaffenburg, Germany
  • Gartenstr. 3,76889 Schweigen, Germany
  • Großbottwarer Str. 47, 71720 Oberstenfeld, Germany
  • Hanseatenplatz 1, 25524 Itzehoe, Germany
  • Hauptstr. 165, 42579 Heiligenhaus, Germany
  • Hauptstr. 240, 77694 Kehl, Germany
  • Hauptstr. 46, 37083 Göttingen, Germany
  • Josef-Sugg-Str. 5, 88348 Bad Saulgau, Germany
  • Kapellenstraße 27, 47533 Kleve-Materborn, Germany
  • Kleinenbroicher Str. 68, 41352 Korschenbroich, Germany
  • Kuhtrift 8a, 34414 Warburg, Germany
  • Langenbeckstraße 1, 55101 Mainz, Germany
  • Lindenpromenade 34b, 39164 Wanzleben, Germany
  • Lindenstr. 9, 25524 Itzehoe, Germany
  • Marienstraße 2, 44866 Bochum, Germany
  • Maschstr. 8a, 49565 Bramsche, Germany
  • Mose-Stern-Str. 28, 41236 Mönchengladbach, Germany
  • Ostlandstr. 10, 32339 Espelkamp, Germany
  • Poststr. 10, 34225 Baunatal, Germany
  • Tangstedter Landstr 77, 22415 Hamburg, Germany
  • Wilhelmshöher Allee 109, 34121 Kassel, Germany
  • Würzburger Str. 1, 97941 Tauberbischofsheim, Germany
• Italy
  • C.so Mazzini 18, 28100 Novar, Italy
  • Current address: Via Luca Giordano n. 13, 50132 Firenze, Italy
  • Piazza Ospedale 10, 20900 Lodi, Italy
  • Via Commenda 9, 20122, Milano, Italy
  • Via Consolare Valeria 1, 98125 Messina, Italy
  • Via G.B.Grossi 74, 20157 Milano, Italy
  • Via Giustiniani,3, 35128 Padova, Italy
  • Via Pastore 1,16132 Genova, Italy
  • Via Siracusa, 45, 90143 Palermo, Italy
  • Viale Pieraccini n. 24 50139 Firenze, Italy
• Spain
  • Avda. Rambleta, s/n Catarroja Valencia, Spain
  • C/ Tossal del Rei nº 7 Castellón de la Plana Castellón, Spain
  • Catarroja Esquina Ministro Serrano. Paiporta Valencia, Spain
  • Celestino Villamil, s/n Oviedo, Spain
  • Ctra. Anfondeguilla, s/n Vall Duixo Castellón, Spain
  • Isabel de Villena,2 Pabellón Valencia, Spain
  • Molí s/n Puçol Valencia, Spain
  • Médico Fernando Moray de la Horra, 2 acceso Y9 Valencia, Spain
  • Pedro s/n Almazora Castellón, Spain
  • Pizarro, 22 Vigo Pontevedra, Spain
  • Plaza Blasco Ibañez, 4 Sagunto Valencia, Spain
  • Plaza Segovia s/n Valencia, Spain
  • República Argentina nº 8, Valencia, Spain
  • Rosales, 23 La Eliana Valencia, Spain
  • Serreria,73 Valencia, Spain
  • Travesía da Choupana, s/n Santiago de Compostela A Coruña, Spain
• United Kingdom
  • Oxford, United Kingdom, OX3 7LJ
    • Centre for Clinical Vaccinology
  • Bristol
    • Marlborough Street, Bristol, United Kingdom, BS1 3NU
      • University Hospitals Bristol, NHS Foundation Trust, Trust Headquarters
  • Exeter
    • Barrack Road, Exeter, United Kingdom, EX2 5DW
      • South West Medicines for Children Research Network, Child Health Building, Royal Devon and Exeter NHS Foundation Trust
  • London
    • Cranmer Terrace, London, United Kingdom, SW17 0RE
      • St. George's University of London
  • Oxford
    • Headington, Oxford, United Kingdom, OX3 7LJ
      • Oxford Vaccines Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Follow-on participants of V72P12:

Healthy toddlers who completed Study V72P12, aged:

• 12 months or older - Groups 1a, 2a, 3a, 4
• 18 months (0/ +29 days window) - Groups 1b, 2b, 3b
• 24 months (0/ +29 days window) - Groups 1c, 2c, 3c

Naive subjects newly enrolled:

• Group 5: healthy 18-month-old toddlers (0/ +29 days window)
• Group 6: healthy 24-month-old toddlers (0/ +29 days window)

Exclusion Criteria:

• History of any meningococcal B vaccine administration (only for groups 5 and 6);
• Previous ascertained or suspected disease caused by N. meningitidis;
• History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
• Significant acute or chronic infection within the previous 7 days or axillary temperature major or equal to 38 degrees within the previous day
• Antibiotics within 6 days prior to enrollment;
• Any serious chronic or progressive disease;
• Known or suspected impairment or alteration of the immune system;
• Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: B+R246_12; Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine 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 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 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: 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: 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
Experimental: B+R246_18; Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 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 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 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: 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: 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
Experimental: B+R246_24; Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 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 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 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: 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: 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
Experimental: B246_12; Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine 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 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; 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
Experimental: B246_18; Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by 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; 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
Experimental: B246_24; Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 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; 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
Experimental: B+R234_12; Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by 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 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 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: 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: 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
Experimental: B+R234_18; Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 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 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 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: 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: 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
Experimental: B+R234_24; Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 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 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 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: 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: 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
Experimental: B12 14; Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 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: two doses of rMenB+OMV NZ; two catch-up doses of rMenB+OMV NZ at 18 and 20 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
Experimental: B18 20; Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 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: two doses of rMenB+OMV NZ; two catch-up doses of rMenB+OMV NZ at 18 and 20 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
Experimental: B24 26; Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 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: two doses of rMenB+OMV NZ; two catch-up doses of rMenB+OMV NZ at 18 and 20 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 4 and 6 Months of Age.	Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 4 and 6 months of age.	1 month after booster

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentages of Subjects With SBA Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 4 and 6 Months of Age and Routine Vaccines at 3, 5 and 7 Months of Age.	Immunogenicity was assessed in terms of Percentages of Subjects With SBA Titers ≥1:5 (98.3% CI), After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in subjects who previously received 3 doses of rMenB+OMV NZ at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age.	1 month after booster
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 3 and 4 Months of Age.	Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 3 and 4 months of age.	1 month after booster
Geometric Mean Titers (GMTs) in Subjects One Month After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects at 12 18 or 24 Months of Age Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age.	The serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.	1 month after booster
GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 12 Months of Age Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age	Characterization of immunological memory by serum antibody titers (98.3% CI) one month after the fourth (booster) dose of meningococcal B vaccine at 12 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.	1 month after booster
GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 18 and 24months of Age, Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age	Characterization of immunological memory by serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.	1 month after booster
Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months	Immunogenicity evaluation of a two-dose catch-up regimen of rMenB+OMV NZ in unprimed toddlers aged 12, 18 or 24 months as measured by serum antibody titers one month after the second vaccination f meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.	1 month after second vaccination
Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Fourth Booster Dose to Previously Primed Toddlers at 12, 18 or 24 Months of Age.	Immunogenicity evaluation against vaccine antigen 287-953 one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months measured by ELISA.	1 month after booster vaccination
Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Booster Given After a Two-dose Catch-up Regimen in Toddlers Starting at 12, 18 or 24 Months of Age.	Immunogenicity evaluation against vaccine antigen 287-953 one month after booster given after a two-dose catch-up regimen in toddlers starting at 12, 18 or 24 months of age.one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months of age measured by ELISA	1 month after booster vaccination
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.	The safety and tolerability of the 4th booster dose rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.	From day 1 to day 7 after vaccination
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.	The safety and tolerability of the two-dose catch-up regimen of rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.	day 1 to day 7 after vaccination

Collaborators and Investigators

• Sponsor: Novartis Vaccines
• Collaborators: GlaxoSmithKline

Publications and helpful links

General Publications

• Bartolini E, Borgogni E, Bruttini M, Muzzi A, Giuliani M, Iozzi S, Petracca R, Martinelli M, Bonacci S, Marchi S, Brettoni C, Donati C, Torricelli G, Guidotti S, Domina M, Beninati C, Teti G, Felici F, Rappuoli R, Castellino F, Del Giudice G, Masignani V, Pizza M, Maione D. Immunological fingerprint of 4CMenB recombinant antigens via protein microarray reveals key immunosignatures correlating with bactericidal activity. Nat Commun. 2020 Oct 5;11(1):4994. doi: 10.1038/s41467-020-18791-0.
• Snape MD, Voysey M, Finn A, Bona G, Esposito S, Principi N, Diez-Domingo J, Sokal E, Kieninger D, Prymula R, Dull PM, Kohl I, Barone M, Wang H, Toneatto D, Pollard AJ; European MenB Vaccine Study Group. Persistence of Bactericidal Antibodies After Infant Serogroup B Meningococcal Immunization and Booster Dose Response at 12, 18 or 24 Months of Age. Pediatr Infect Dis J. 2016 Apr;35(4):e113-23. doi: 10.1097/INF.0000000000001056. Erratum In: Pediatr Infect Dis J. 2020 Jul;39(7):e162.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: July 21, 2009
• First Submitted That Met QC Criteria: July 21, 2009
• First Posted (Estimate): July 22, 2009

Study Record Updates

• Last Update Posted (Actual): August 14, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: prevention; Meningococcal meningitis; vaccination; toddler
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Neisseriaceae Infections; Meningitis, Meningococcal; Meningitis; Meningococcal Infections
• Other Study ID Numbers: V72P12E1; 2009-011676-30