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

NCT00944034 | Completed Phase 2 Results

• 2 other identifiers: V72P12E12009-011676-30
• Study Type: interventional
• Target: 1,588
• Locations: 6 countries
• Sites: 72

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

Keywords

Meningococcal meningitis; prevention; vaccination; toddler

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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.

  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.

  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.

  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

  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

  1 month after booster

Study Arms (12)

B+R246_12

EXPERIMENTAL

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

B+R246_18

EXPERIMENTAL

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

B+R246_24

EXPERIMENTAL

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

B246_12

EXPERIMENTAL

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

B246_18

EXPERIMENTAL

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

B246_24

EXPERIMENTAL

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

B+R234_12

EXPERIMENTAL

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

B+R234_18

EXPERIMENTAL

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

B+R234_24

EXPERIMENTAL

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

B12 14

EXPERIMENTAL

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

Biological: two doses of rMenB+OMV NZ

B18 20

EXPERIMENTAL

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

B24 26

EXPERIMENTAL

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

Interventions

rMenB+OMV NZ with routine vaccinations 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_12

rMenB+OMV NZ 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_12

two doses of rMenB+OMV NZ BIOLOGICAL

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

B12 14

Eligibility Criteria

• Age: 12 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Follow-on participants of V72P12:
• Healthy toddlers who completed Study V72P12, aged:
• months or older - Groups 1a, 2a, 3a, 4
• months (0/ +29 days window) - Groups 1b, 2b, 3b
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Vaccines: lead
• GlaxoSmithKline: collaborator

Study Sites (72)

Unknown Facility

Avenue Albert 1er 185, 5000 Namur, Belgium

Location

Unknown Facility

Avenue Hippocrate 10, 1200 Brussels, Belgium

Location

Unknown Facility

Laarbeeklaan 101, 1090 Brussels, Belgium

Location

Unknown Facility

Lindendreef 1, 2020 Antwerpen, Belgium

Location

Unknown Facility

Sint Vincentiusstraat 20, 2018 Antwerpen, Belgium

Location

Unknown Facility

Stadsomvaart 11, 3500 Hasselt, Belgium

Location

Unknown Facility

Wilrijkstraat 10, 2650 Edegem, Belgium

Location

Unknown Facility

Červený Kostelec, 549 41, Czechia

Location

Unknown Facility

Kyjevska 44, 532 03 Pardubice, Czechia

Location

Unknown Facility

Ruskych Legii 352, 377 01 Jindrichuv Hradec, Czechia

Location

Unknown Facility

Trebesska 1575, 500 01 Hradec Kralove, Czechia

Location

Unknown Facility

Ahrensböker Str. 11, 23617 Stockelsdorf, Germany

Location

Unknown Facility

Am Alten Hafen 117, 27568 Bremerhaven, Germany

Location

Unknown Facility

Ammertalweg 7, 99086 Erfurt, Germany

Location

Unknown Facility

Anne Frank Str.27, 75015 Bretten, Germany

Location

Unknown Facility

Bucher Chaussee 1-3, 13125 Berlin, Germany

Location

Unknown Facility

Christian-Bauer-Str.5, 73642 Welzheim, Germany

Location

Unknown Facility

Deckertstr. 53, 33645 Bielefeld, Germany

Location

Unknown Facility

Dingbängerweg 69, 48163 Münster, Germany

Location

Unknown Facility

Elisenstr. 28, 63739 Aschaffenburg, Germany

Location

Unknown Facility

Gartenstr. 3,76889 Schweigen, Germany

Location

Unknown Facility

Großbottwarer Str. 47, 71720 Oberstenfeld, Germany

Location

Unknown Facility

Hanseatenplatz 1, 25524 Itzehoe, Germany

Location

Unknown Facility

Hauptstr. 165, 42579 Heiligenhaus, Germany

Location

Unknown Facility

Hauptstr. 240, 77694 Kehl, Germany

Location

Unknown Facility

Hauptstr. 46, 37083 Göttingen, Germany

Location

Unknown Facility

Josef-Sugg-Str. 5, 88348 Bad Saulgau, Germany

Location

Unknown Facility

Kapellenstraße 27, 47533 Kleve-Materborn, Germany

Location

Unknown Facility

Kleinenbroicher Str. 68, 41352 Korschenbroich, Germany

Location

Unknown Facility

Kuhtrift 8a, 34414 Warburg, Germany

Location

Unknown Facility

Langenbeckstraße 1, 55101 Mainz, Germany

Location

Unknown Facility

Lindenpromenade 34b, 39164 Wanzleben, Germany

Location

Unknown Facility

Lindenstr. 9, 25524 Itzehoe, Germany

Location

Unknown Facility

Marienstraße 2, 44866 Bochum, Germany

Location

Unknown Facility

Maschstr. 8a, 49565 Bramsche, Germany

Location

Unknown Facility

Mose-Stern-Str. 28, 41236 Mönchengladbach, Germany

Location

Unknown Facility

Ostlandstr. 10, 32339 Espelkamp, Germany

Location

Unknown Facility

Poststr. 10, 34225 Baunatal, Germany

Location

Unknown Facility

Tangstedter Landstr 77, 22415 Hamburg, Germany

Location

Unknown Facility

Wilhelmshöher Allee 109, 34121 Kassel, Germany

Location

Unknown Facility

Würzburger Str. 1, 97941 Tauberbischofsheim, Germany

Location

Unknown Facility

C.so Mazzini 18, 28100 Novar, Italy

Location

Unknown Facility

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

Location

Unknown Facility

Piazza Ospedale 10, 20900 Lodi, Italy

Location

Unknown Facility

Via Commenda 9, 20122, Milano, Italy

Location

Unknown Facility

Via Consolare Valeria 1, 98125 Messina, Italy

Location

Unknown Facility

Via G.B.Grossi 74, 20157 Milano, Italy

Location

Unknown Facility

Via Giustiniani,3, 35128 Padova, Italy

Location

Unknown Facility

Via Pastore 1,16132 Genova, Italy

Location

Unknown Facility

Via Siracusa, 45, 90143 Palermo, Italy

Location

Unknown Facility

Viale Pieraccini N. 24 50139 Firenze, Italy

Location

Unknown Facility

Avda. Rambleta, S/n Catarroja Valencia, Spain

Location

Unknown Facility

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

Location

Unknown Facility

Catarroja Esquina Ministro Serrano. Paiporta Valencia, Spain

Location

Unknown Facility

Celestino Villamil, S/n Oviedo, Spain

Location

Unknown Facility

Ctra. Anfondeguilla, S/n Vall Duixo Castellón, Spain

Location

Unknown Facility

Isabel de Villena,2 Pabellón Valencia, Spain

Location

Unknown Facility

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

Location

Unknown Facility

Molí S/n Puçol Valencia, Spain

Location

Unknown Facility

Pedro S/n Almazora Castellón, Spain

Location

Unknown Facility

Pizarro, 22 Vigo Pontevedra, Spain

Location

Unknown Facility

Plaza Blasco Ibañez, 4 Sagunto Valencia, Spain

Location

Unknown Facility

Plaza Segovia S/n Valencia, Spain

Location

Unknown Facility

República Argentina Nº 8, Valencia, Spain

Location

Unknown Facility

Rosales, 23 La Eliana Valencia, Spain

Location

Unknown Facility

Serreria,73 Valencia, Spain

Location

Unknown Facility

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

Location

University Hospitals Bristol, NHS Foundation Trust, Trust Headquarters

Marlborough Street, Bristol, BS1 3NU, United Kingdom

Location

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

Barrack Road, Exeter, EX2 5DW, United Kingdom

Location

St. George's University of London

Cranmer Terrace, London, SW17 0RE, United Kingdom

Location

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

Headington, Oxford, OX3 7LJ, United Kingdom

Location

Centre for Clinical Vaccinology

Oxford, OX3 7LJ, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 33020485 DERIVED

• 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.

  PMID: 26756390 DERIVED

MeSH Terms

Conditions

Meningococcal Infections; Meningitis, Meningococcal

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Limitations and Caveats

None reported

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines

anh.phung@novartis.com

+39 0577 245863

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 22, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: January 1, 2012
• Last Updated: August 14, 2017
• Results First Posted: November 10, 2015

Record last verified: 2017-07

Locations

DE (30); CZ (4); BE (7); GB (5); IT (10); ES (16)