Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules

Phase 2

Completed

Conditions: Meningococcal Disease

Interventions: Biological: rMenB+OMV NZ
Biological: Placebo

Registration Number: NCT00661713

Lead Sponsor: Novartis Vaccines

Brief Summary: The proposed study is aimed to assess the antibody response and short-term persistence of Novartis Meningococcal B Vaccine after one, two or three doses and to evaluate the optimal vaccination schedule in an adolescent population.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1631

Inclusion Criteria

1)11-17 years of age inclusive who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment;

2)who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period);

3)in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria

History of any meningococcal B vaccine administration;
Current or previous, confirmed or suspected disease caused by N. meningitidis;
Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥38°C) within the previous day;
Antibiotics within 6 days prior to enrollment;
Pregnancy or nursing (breastfeeding) mothers;
Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the 7 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry;
Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition).
Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids within the previous 60 days. [Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body is allowed]; immunostimulants;
Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
Receipt of or intent to immunize with any other vaccine(s) within 30 days prior (60 days for live viral vaccines) and throughout the study period (exception: licensed fluvaccine should not be administered within 14 days prior to enrollment; routine vaccine administration may be administered after the blood draw at Study Month 7);
Participation in another clinical trial within the last 90 days or planned for during study;
Family members and household members of research staff;
Any condition which in the opinion of the investigator and/or the Regional MD may interfere with the evaluation of the study objectives.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rMenB6	Placebo	Subjects received three injections of placebo(at month 0, month 1 and month 2) and one injection of rMenB+OMV NZ vaccine(at month 6).
rMenB06	Placebo	Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and two injections of placebo (at month 1, month 2). A second injection of rMenB+OMV NZ vaccine was given later (month 6).
rMenB016	rMenB+OMV NZ	Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6).
rMenB026	Placebo	Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6).
rMenB0	rMenB+OMV NZ	Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and three injections of placebo (month 1, month 2 and month 6).
rMenB02	rMenB+OMV NZ	Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and two injections of placebo (at month 1 and month 6).
rMenB0	Placebo	Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and three injections of placebo (month 1, month 2 and month 6).
rMenB01	Placebo	Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and two injection of placebo (at month 2 and month 6).
rMenB026	rMenB+OMV NZ	Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6).
rMenB06	rMenB+OMV NZ	Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and two injections of placebo (at month 1, month 2). A second injection of rMenB+OMV NZ vaccine was given later (month 6).
rMenB016	Placebo	Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6).
rMenB012	rMenB+OMV NZ	Subjects received three injections of rMenB+OMV NZ vaccine (at month 0, month 1 and month 2) and one injection of placebo later (at month 6).
rMenB012	Placebo	Subjects received three injections of rMenB+OMV NZ vaccine (at month 0, month 1 and month 2) and one injection of placebo later (at month 6).
rMenB01	rMenB+OMV NZ	Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and two injection of placebo (at month 2 and month 6).
rMenB02	Placebo	Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and two injections of placebo (at month 1 and month 6).
rMenB6	rMenB+OMV NZ	Subjects received three injections of placebo(at month 0, month 1 and month 2) and one injection of rMenB+OMV NZ vaccine(at month 6).

Primary Outcome Measures

Name	Time	Method
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.	Month-1, 2, 3	Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter \>1:4 against 44/76-SL, 5/99, NZ98/254 strains at months 1, 2, 3.
Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination	1 to 7 days after each vaccination	Safety was assessed as the number of subjects who reported local and systemic reactions during day 1 to day 7 after any vaccination with rMenB+OMV

Secondary Outcome Measures

Name	Time	Method
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.	Month-6 & 7	Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter \>1:4 agains 44/76-SL, 5/99, NZ98/254 strains at months 6 \& 7.
Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.	Month-1, month-2, month-3 and month-7	Immunogenicity was evaluated by measuring the percentage of subjects with at least a fourfold rise in hSBA titer over the prevaccination and after booster vaccination against 44/76-SL, 5/99, NZ98/254 strains at month-1, month-2, month-3 and month-7.
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.	month-1, month-2, month-3, month-6 and month-7	Immunogenicity was evaluated by measuring the Geometric mean ratios (GMRs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.
Number of Subjects Reporting Unsolicited AEs Throughout the Study.	Throughout the study	Safety was assessed as the number of subjects who reported unsolicited AEs throughout the study.
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.	at baseline, month-1, month-2, month-3, month-6 and month-7.	Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titer ≥1:8 against 44/76-SL, 5/99, NZ98/254 strains.
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.	month-1, month-2, month-3, month-6 and month-7	Immunogenicity was evaluated by measuring the Geometric mean titers (GMTs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.
GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.	month-1, month-2, month-3, month-6 and month-7	Immunogenicity was evaluated by measuring the Geometric mean Concentration (GMCs) after primary and booster vaccination against Antigen 287-953 Antigen.
GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination	month-1, month-2, month-3, month-6 and month-7	Immunogenicity was evaluated by measuring the Geometric mean Ratios (GMRs) after primary and booster vaccination against 287-953Antigen

Trial Locations

Locations (10): Site 43: Liceo José Victorino Lastarria
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Av. Miguel Claro N° 32, Chile
Site 15: Liceo Carmela Carvajal de Prat
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Avda. Italia 980, Chile
Site 14: Colegio Parroquial Santa Rosa de Lo Barnechea
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Avda. Raúl Labbé Nº 13.799, Chile
Site 11: Complejo Educacional Eduardo Cuevas Valdés
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Lo Barnechea, Chile
Site 13: Liceo Diego Aracena de Lo Barnechea
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Monseñor Escrivá De Balaguer 14630, Lo Barnechea, Santiago, Chile
Site 41: Colegio Antonio Hermida Fabres
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Av. Coronel Alejandro Sepúlveda N° 6801, Chile
Site 51: Centro Para vacunas en Desarrollo. Hospital de Niños Roberto del Rio
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Av. Prof Zañartu 1085, Chile
Site 61: Facultad de Medicina. Universidad de Valparaíso.
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Hontaneda # 2653. Valparaíso, Chile
Site 42: Centro Educacional Eduardo de la Barra
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Calle A, N° 6301, Chile
Site 12: Colegio San Jose de Lo Barnechea
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Santiago, Chile