Clinical trial NCT00661713: Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules
Official title: A Phase 2b/3, Multi-Center, Observer-Blind, Controlled Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents Aged 11-17 Years According to Different Vaccination Schedules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Meningococcal Disease
Keywords: Meningococcal disease
Neisseria meningitidis serogroup B
prevention
vaccination
adolescents
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 1631
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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:

1. History of any meningococcal B vaccine administration;
2. Current or previous, confirmed or suspected disease caused by N. meningitidis;
3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
4. Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥38°C) within the previous day;
5. Antibiotics within 6 days prior to enrollment;
6. Pregnancy or nursing (breastfeeding) mothers;
7. 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;
8. 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).
9. 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;
10. Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
11. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
12. 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);
13. Participation in another clinical trial within the last 90 days or planned for during study;
14. Family members and household members of research staff;
15. Any condition which in the opinion of the investigator and/or the Regional MD may interfere with the evaluation of the study objectives.

Primary outcomes:
measure: Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
timeFrame: Month-1, 2, 3
measure: Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination
timeFrame: 1 to 7 days after each vaccination
Secondary outcomes:
measure: Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.
timeFrame: Month-6 & 7
measure: Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
timeFrame: at baseline, month-1, month-2, month-3, month-6 and month-7.
measure: Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.
timeFrame: Month-1, month-2, month-3 and month-7
measure: Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
timeFrame: month-1, month-2, month-3, month-6 and month-7
measure: Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
timeFrame: month-1, month-2, month-3, month-6 and month-7
measure: GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.
timeFrame: month-1, month-2, month-3, month-6 and month-7
measure: GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination
timeFrame: month-1, month-2, month-3, month-6 and month-7
measure: Number of Subjects Reporting Unsolicited AEs Throughout the Study.
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Monseñor Escrivá De Balaguer 14630, Lo Barnechea
country: Chile
facility: Site 13: Liceo Diego Aracena de Lo Barnechea
state: Santiago
city: Av. Coronel Alejandro Sepúlveda N° 6801
country: Chile
facility: Site 41: Colegio Antonio Hermida Fabres
city: Av. Miguel Claro N° 32
country: Chile
facility: Site 43: Liceo José Victorino Lastarria
city: Av. Prof Zañartu 1085
country: Chile
facility: Site 51: Centro Para vacunas en Desarrollo. Hospital de Niños Roberto del Rio
city: Avda. Italia 980
country: Chile
facility: Site 15: Liceo Carmela Carvajal de Prat
city: Avda. Raúl Labbé Nº 13.799
country: Chile
facility: Site 14: Colegio Parroquial Santa Rosa de Lo Barnechea
city: Calle A, N° 6301
country: Chile
facility: Site 42: Centro Educacional Eduardo de la Barra
city: Hontaneda # 2653. Valparaíso
country: Chile
facility: Site 61: Facultad de Medicina. Universidad de Valparaíso.
city: Lo Barnechea
country: Chile
facility: Site 11: Complejo Educacional Eduardo Cuevas Valdés
city: Santiago
country: Chile
facility: Site 12: Colegio San Jose de Lo Barnechea
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
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: Santolaya ME, O'Ryan ML, Valenzuela MT, Prado V, Vergara R, Munoz A, Toneatto D, Grana G, Wang H, Clemens R, Dull PM; V72P10 Meningococcal B Adolescent Vaccine Study group. Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b/3 randomised, observer-blind, placebo-controlled study. Lancet. 2012 Feb 18;379(9816):617-24. doi: 10.1016/S0140-6736(11)61713-3. Epub 2012 Jan 18.