Clinical trial NCT00721396: Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules
Official title: A Phase 2b, Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningococcal Infections
Keywords: Meningococcal disease,
Neisseria meningitidis serogroup B,
Prevention,
Vaccination,
Infants
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-07-24
Enrollment: 1885
Sex: ALL
Minimum age (years): 55
Maximum age (years): 89
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Primary :1.To demonstrate a sufficient immune response of rMenB+OMV NZ, when given concomitantly with routine infant vaccines to healthy infants at 2, 4 and 6 and 2, 3 and 4 months of age, as measured by percentage of subjects with serum bactericidal activity (SBA) titer ≥1:5, at 1 month after the third vaccination Secondary :To demonstrate that immunogenicity of routine infant vaccines, when given concomitantly with rMenB+OMV NZ to healthy infants at 2, 3 and 4 months of age, was non-inferior to that of routine infant vaccines given without rMenB+OMV NZ. 2. To demonstrate that the immunogenicity of rMenB+OMV NZ when given concomitantly with routine infant vaccines was non-inferior to that of rMenB+OMV NZ given without routine infant vaccines at 2, 4 and 6 months of age. 3. To assess prevalence of meningococcal B antibodies over the study period by evaluation of SBA, at baseline and at 1 month after third vaccination, in subjects- received routine infant vaccine without rMenB+OMV NZ.


Eligibility criteria: Inclusion Criteria:

* Healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg;
* For whom a parent/legal guardian has given written informed consent after the nature of the study has been explained.

Exclusion Criteria:

* History of any meningococcal B or C vaccine administration;
* prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens);
* 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 to38 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: Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine
timeFrame: One month after third Men B vaccination
measure: Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age
timeFrame: 10 months (groups 1 and 2); 8 months (groups 3 and 4)
Secondary outcomes:
measure: Non-inferiority of Immune Response to rMenB+OMV NZ Vaccination When Administered Concomitantly With Routine Infant Vaccines at 2,4,6 Months of Age
timeFrame: One month after 3rd Men B vaccination
measure: Non-inferiority of Immune Response to Diphtheria and Tetanus Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine
timeFrame: One month after 3rd vaccination
measure: Geometric Mean Titers Against Neisseria Meningitidis Serogroup B, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
timeFrame: One month after third Men B vaccination
measure: Geometric Mean Ratio of hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
timeFrame: one month after third Men B vaccination
measure: Percentage of Subjects With hSBA ≥1:8 After Receiving Three Doses of rMenB+OMV NZ Vaccine.
timeFrame: One month after third Men B vaccination
measure: Percentage of Subjects With 4-fold Rise in hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
timeFrame: One month after third Men B vaccination
measure: Non-inferiority of Immune Response to Acellular Pertussis Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine.
timeFrame: 1 month after 3rd vaccination
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Novartis Investigational Site Nr. 59
state: Antwerpen
city: Brussels
country: Belgium
facility: Study Investigational Site Nr. 60
state: Brussels-Capital Region
city: Brussels
country: Belgium
facility: Novartis Investigational Site Nr. 57
state: Brussels-Capital Region
city: Hasselt
country: Belgium
facility: Novartis Investigational Site Nr. 56
state: Limburg
city: Antwerp
country: Belgium
facility: Novartis Investigational Site Nr. 55
city: Namur
country: Belgium
facility: Novartis Investigational Site Nr. 58
city: Červený Kostelec
country: Czech Republic
facility: Novartis Investigational Site Nr. 95
state: Hradec Králové
city: Jindřichův Hradec
country: Czech Republic
facility: Novartis Investigational Site Nr. 96
state: South Bohemian
city: Hradec Králové
country: Czech Republic
facility: Novartis Investigational Site Nr. 93
city: Pardubice
country: Czech Republic
facility: Novartis Investigational Site Nr. 94
city: Bad Saulgau
country: Germany
facility: Novartis Investigational Site Nr. 68
state: Baden-Württemberg
city: Bretten
country: Germany
facility: Novartis Investigational Site Nr. 65
state: Baden-Württemberg
city: Kehl
country: Germany
facility: Novartis Investigational Site Nr. 62
state: Baden-Württemberg
city: Oberstenfeld
country: Germany
facility: Novartis Investigational Site Nr. 64
state: Baden-Württemberg
city: Welzheim
country: Germany
facility: Novartis Investigational Site Nr. 66
state: Baden-Württemberg
city: Aschaffenburg
country: Germany
facility: Novartis Investigational Site Nr. 69
state: Bavaria
city: Bremerhaven
country: Germany
facility: Novartis Investigational Site Nr. 71
state: Bremen
city: Baunatal
country: Germany
facility: Novartis Investigational Site Nr. 73
state: Hesse
city: Bramsche
country: Germany
facility: Novartis Investigational Site Nr. 75
state: Lower Saxony
city: Bochum
country: Germany
facility: Novartis Investigational Site Nr. 81
state: North Rhine-Westphalia
city: Heiligenhaus
country: Germany
facility: Novartis Investigational Site Nr. 79
state: North Rhine-Westphalia
city: Kleve Materborn
country: Germany
facility: Novartis Investigational Site Nr. 80
state: North Rhine-Westphalia
city: Monchengladbach
country: Germany
facility: Novartis Investigational Site Nr. 78
state: North Rhine-Westphalia
city: Munster
country: Germany
facility: Novartis Investigational Site Nr. 82
state: North Rhine-Westphalia
city: Warburg
country: Germany
facility: Novartis Investigational Site Nr. 83
state: North Rhine-Westphalia
city: Bielefeld
country: Germany
facility: Novartis Investigational Site Nr. 85
state: North-Rhine Westphalia
city: Mainz
country: Germany
facility: Novartis Investigational Site Nr. 61
state: Rhineland-Palatinate
city: Schweigen
country: Germany
facility: Novartis Investigational Site Nr. 67
state: Rhineland-Palatinate
city: Wanzleben
country: Germany
facility: Novartis Investigational Site Nr. 86
state: Saxony-Anhalt
city: Itzenhoe
country: Germany
facility: Novartis Investigational Site Nr. 88
state: Schleswig-Holstein
city: Itzenhoe
country: Germany
facility: Novartis Investigational Site Nr. 89
state: Schleswig-Holstein
city: Stockelsdorf
country: Germany
facility: Novartis Investigational Site Nr. 87
state: Schleswig-Holstein
city: Erfurt
country: Germany
facility: Novartis Investigational Site Nr. 90
state: Thuringia
city: Berlin
country: Germany
facility: Novartis Investigational Site Nr. 70
city: Hamburg
country: Germany
facility: Novartis Investigational Site Nr. 72
city: Milano
country: Italy
facility: Novartis Investigational Site Nr. 5
state: Lombardy
city: Milano
country: Italy
facility: Novartis Investigational Site Nr. 52
state: Lombardy
city: Novara
country: Italy
facility: Novartis Investigational Site Nr. 6
state: Piedmont
city: Firenze
country: Italy
facility: Novartis Investigational Site Nr. 7
state: Tuscany
city: Padova
country: Italy
facility: Novartis Investigational Site Nr. 9
state: Veneto
city: Santiago de Compostela
country: Spain
facility: Novartis Investigational Site Nr. 46
state: A Coruña
city: Oviedo
country: Spain
facility: Novartis Investigational Site Nr. 49
state: Asturias
city: Almassora
country: Spain
facility: Novartis Investigational Site Nr. 11
state: Castellón
city: Castellon de la Plana
country: Spain
facility: Novartis Investigational Site Nr. 10
state: Castellón
city: Vall D'Uixo
country: Spain
facility: Novartis Investigational Site Nr. 12
state: Castelló
city: Vigo Pontevedra
country: Spain
facility: Novartis Investigational Site Nr. 48
state: Pontevedra
city: Catarroja
country: Spain
facility: Novartis Investigational Site Nr. 25
state: Valencia
city: La Eliana
country: Spain
facility: Novartis Investigational Site Nr. 21
state: Valencia
city: Sagunto
country: Spain
facility: Novartis Investigational Site 14
state: Valencia
city: Valencia
country: Spain
facility: Novartis Investigational Site Nr. 17
city: Valencia
country: Spain
facility: Novartis Investigational Site Nr. 24
city: Valencia
country: Spain
facility: Novartis Investigational Site Nr. 15
city: Valencia
country: Spain
facility: Novartis Investigational Site Nr. 18
city: Valencia
country: Spain
facility: Novartis Investigational Site Nr. 19
city: Valencia
country: Spain
facility: Novartis Investigational Site Nr. 16
city: Valencia
country: Spain
facility: Novartis Investigational Site Nr. 23
city: Oxford
country: United Kingdom
facility: Novartis Investigational Site Nr. 1
state: South East England
city: Bristol
country: United Kingdom
facility: Novartis Investigational Site 3
state: South West England
city: Exeter
country: United Kingdom
facility: Novartis Investigational Site Nr. 4
state: South West England
city: London
country: United Kingdom
facility: Novartis Investigational Site Nr. 2
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Zafack JG, Bureau A, Skowronski DM, De Serres G. Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials. BMJ Open. 2019 May 19;9(5):e026953. doi: 10.1136/bmjopen-2018-026953.
citation: Gossger N, Snape MD, Yu LM, Finn A, Bona G, Esposito S, Principi N, Diez-Domingo J, Sokal E, Becker B, Kieninger D, Prymula R, Dull P, Ypma E, Toneatto D, Kimura A, Pollard AJ; European MenB Vaccine Study Group. Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. JAMA. 2012 Feb 8;307(6):573-82. doi: 10.1001/jama.2012.85.