Clinical trial NCT00944034: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Meningococcal Disease
Meningococcal Meningitis
Keywords: Meningococcal meningitis
prevention
vaccination
toddler
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2009-07-22
Enrollment: 1588
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 1 month after booster
Secondary outcomes:
measure: 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.
timeFrame: 1 month after booster
measure: 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.
timeFrame: 1 month after booster
measure: 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.
timeFrame: 1 month after booster
measure: 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
timeFrame: 1 month after booster
measure: 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
timeFrame: 1 month after booster
measure: Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months
timeFrame: 1 month after second vaccination
measure: 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.
timeFrame: 1 month after booster vaccination
measure: 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.
timeFrame: 1 month after booster vaccination
measure: 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.
timeFrame: From day 1 to day 7 after vaccination
measure: 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.
timeFrame: day 1 to day 7 after vaccination
Other outcomes:
Locations:
city: Avenue Albert 1er 185, 5000 Namur
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city: Avenue Hippocrate 10, 1200 Brussels
country: Belgium
city: Laarbeeklaan 101, 1090 Brussels
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city: Lindendreef 1, 2020 Antwerpen
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city: Sint Vincentiusstraat 20, 2018 Antwerpen
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city: Trebesska 1575, 500 01 Hradec Kralove
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city: Hanseatenplatz 1, 25524 Itzehoe
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city: Hauptstr. 240, 77694 Kehl
country: Germany
city: Hauptstr. 46, 37083 Göttingen
country: Germany
city: Josef-Sugg-Str. 5, 88348 Bad Saulgau
country: Germany
city: Kapellenstraße 27, 47533 Kleve-Materborn
country: Germany
city: Kleinenbroicher Str. 68, 41352 Korschenbroich
country: Germany
city: Kuhtrift 8a, 34414 Warburg
country: Germany
city: Langenbeckstraße 1, 55101 Mainz
country: Germany
city: Lindenpromenade 34b, 39164 Wanzleben
country: Germany
city: Lindenstr. 9, 25524 Itzehoe
country: Germany
city: Marienstraße 2, 44866 Bochum
country: Germany
city: Maschstr. 8a, 49565 Bramsche
country: Germany
city: Mose-Stern-Str. 28, 41236 Mönchengladbach
country: Germany
city: Ostlandstr. 10, 32339 Espelkamp
country: Germany
city: Poststr. 10, 34225 Baunatal
country: Germany
city: Tangstedter Landstr 77, 22415 Hamburg
country: Germany
city: Wilhelmshöher Allee 109, 34121 Kassel
country: Germany
city: Würzburger Str. 1, 97941 Tauberbischofsheim
country: Germany
city: C.so Mazzini 18, 28100 Novar
country: Italy
city: Current address: Via Luca Giordano n. 13, 50132 Firenze
country: Italy
city: Piazza Ospedale 10, 20900 Lodi
country: Italy
city: Via Commenda 9, 20122, Milano
country: Italy
city: Via Consolare Valeria 1, 98125 Messina
country: Italy
city: Via G.B.Grossi 74, 20157 Milano
country: Italy
city: Via Giustiniani,3, 35128 Padova
country: Italy
city: Via Pastore 1,16132 Genova
country: Italy
city: Via Siracusa, 45, 90143 Palermo
country: Italy
city: Viale Pieraccini n. 24 50139 Firenze
country: Italy
city: Avda. Rambleta, s/n Catarroja Valencia
country: Spain
city: C/ Tossal del Rei nº 7 Castellón de la Plana Castellón
country: Spain
city: Catarroja Esquina Ministro Serrano. Paiporta Valencia
country: Spain
city: Celestino Villamil, s/n Oviedo
country: Spain
city: Ctra. Anfondeguilla, s/n Vall Duixo Castellón
country: Spain
city: Isabel de Villena,2 Pabellón Valencia
country: Spain
city: Molí s/n Puçol Valencia
country: Spain
city: Médico Fernando Moray de la Horra, 2 acceso Y9 Valencia
country: Spain
city: Pedro s/n Almazora Castellón
country: Spain
city: Pizarro, 22 Vigo Pontevedra
country: Spain
city: Plaza Blasco Ibañez, 4 Sagunto Valencia
country: Spain
city: Plaza Segovia s/n Valencia
country: Spain
city: República Argentina nº 8, Valencia
country: Spain
city: Rosales, 23 La Eliana Valencia
country: Spain
city: Serreria,73 Valencia
country: Spain
city: Travesía da Choupana, s/n Santiago de Compostela A Coruña
country: Spain
city: Marlborough Street
country: United Kingdom
facility: University Hospitals Bristol, NHS Foundation Trust, Trust Headquarters
state: Bristol
city: Barrack Road
country: United Kingdom
facility: South West Medicines for Children Research Network, Child Health Building, Royal Devon and Exeter NHS Foundation Trust
state: Exeter
city: Cranmer Terrace
country: United Kingdom
facility: St. George's University of London
state: London
city: Headington
country: United Kingdom
facility: Oxford Vaccines Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road
state: Oxford
city: Oxford
country: United Kingdom
facility: Centre for Clinical Vaccinology
Study officials:
References:
citation: 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.
citation: 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.