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

NCT ID: NCT00944034

Last Updated: 2017-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1588 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2012-01-31

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.

Conditions

Meningococcal Disease; Meningococcal Meningitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

rMenB+OMV NZ with routine vaccinations

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

rMenB+OMV NZ with routine vaccinations

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

rMenB+OMV NZ with routine vaccinations

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

rMenB+OMV NZ

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

rMenB+OMV NZ

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

rMenB+OMV NZ

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

rMenB+OMV NZ with routine vaccinations

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

rMenB+OMV NZ with routine vaccinations

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

rMenB+OMV NZ with routine vaccinations

Intervention Type: BIOLOGICAL

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

B12 14

Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.

Group Type: EXPERIMENTAL

two doses of rMenB+OMV NZ

Intervention Type: BIOLOGICAL

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

B18 20

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

Group Type: EXPERIMENTAL

two doses of rMenB+OMV NZ

Intervention Type: BIOLOGICAL

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

B24 26

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

Group Type: EXPERIMENTAL

two doses of rMenB+OMV NZ

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: BIOLOGICAL

two doses of rMenB+OMV NZ

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

Intervention Type: 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

Intervention Type: BIOLOGICAL

two doses of rMenB+OMV NZ

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

Intervention Type: 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

Intervention Type: BIOLOGICAL

two doses of rMenB+OMV NZ

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

Intervention Type: 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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Červený Kostelec, , Czechia

Kyjevska 44, 532 03 Pardubice, , Czechia

Ruskych Legii 352, 377 01 Jindrichuv Hradec, , Czechia

Trebesska 1575, 500 01 Hradec Kralove, , Czechia

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

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

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

Médico Fernando Moray de La Horra, 2 Acceso Y9 Valencia, , Spain

Molí S/n Puçol 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

University Hospitals Bristol, NHS Foundation Trust, Trust Headquarters

Marlborough Street, Bristol, United Kingdom

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

Barrack Road, Exeter, United Kingdom

St. George's University of London

Cranmer Terrace, London, United Kingdom

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

Headington, Oxford, United Kingdom

Centre for Clinical Vaccinology

Oxford, , United Kingdom

Countries

Belgium; Czechia; Germany; Italy; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 33020485 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26756390 (View on PubMed)

Other Identifiers

2009-011676-30

Identifier Type: -

Identifier Source: secondary_id

V72P12E1

Identifier Type: -

Identifier Source: org_study_id