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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00661713
First received: April 16, 2008
Last updated: October 7, 2015
Last verified: October 2015
  Purpose
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.

Condition Intervention Phase
Meningococcal Disease
Biological: rMenB+OMV NZ
Biological: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentages 'of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine. [ Time Frame: Month-1, 2, 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 to 7 days after each vaccination ] [ Designated as safety issue: Yes ]
    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:
  • Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6. [ Time Frame: Month-6 & 7 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination. [ Time Frame: at baseline, month-1, month-2, month-3, month-6 and month-7. ] [ Designated as safety issue: No ]
    Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titer ≥1:8 against 44/76-SL, 5/99, NZ98/254 strains.

  • Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination. [ Time Frame: Month-1, month-2, month-3 and month-7 ] [ Designated as safety issue: No ]
    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 Titers (GMTs) After Primary and Booster Vaccination. [ Time Frame: month-1, month-2, month-3, month-6 and month-7 ] [ Designated as safety issue: No ]
    Immunogenicity was evaluated by measuring the Geometric mean titers (GMTs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.

  • Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination. [ Time Frame: month-1, month-2, month-3, month-6 and month-7 ] [ Designated as safety issue: No ]
    Immunogenicity was evaluated by measuring the Geometric mean ratios (GMRs) 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. [ Time Frame: month-1, month-2, month-3, month-6 and month-7 ] [ Designated as safety issue: No ]
    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 [ Time Frame: month-1, month-2, month-3, month-6 and month-7 ] [ Designated as safety issue: No ]
    Immunogenicity was evaluated by measuring the Geometric mean Ratios (GMRs) after primary and booster vaccination against 287-953Antigen

  • Number of Subjects Reporting Unsolicited AEs Throughout the Study. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
    Safety was assessed as the number of subjects who reported unsolicited AEs throughout the study.


Enrollment: 1631
Study Start Date: June 2008
Study Completion Date: December 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rMenB06
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).
Biological: rMenB+OMV NZ
Other Name: Serogroup B Meningococcal Vaccine
Biological: Placebo
Experimental: rMenB0
Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and three injections of placebo (month 1, month 2 and month 6).
Biological: rMenB+OMV NZ
Other Name: Serogroup B Meningococcal Vaccine
Biological: Placebo
Experimental: rMenB016
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).
Biological: rMenB+OMV NZ
Other Name: Serogroup B Meningococcal Vaccine
Biological: Placebo
Experimental: rMenB01
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).
Biological: rMenB+OMV NZ
Other Name: Serogroup B Meningococcal Vaccine
Biological: Placebo
Experimental: rMenB026
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).
Biological: rMenB+OMV NZ
Other Name: Serogroup B Meningococcal Vaccine
Biological: Placebo
Experimental: rMenB02
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).
Biological: rMenB+OMV NZ
Other Name: Serogroup B Meningococcal Vaccine
Biological: Placebo
Experimental: rMenB012
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).
Biological: rMenB+OMV NZ
Other Name: Serogroup B Meningococcal Vaccine
Biological: Placebo
Experimental: rMenB6
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).
Biological: rMenB+OMV NZ
Other Name: Serogroup B Meningococcal Vaccine
Biological: Placebo

  Eligibility

Ages Eligible for Study:   11 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661713

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00661713     History of Changes
Other Study ID Numbers: V72P10 
Study First Received: April 16, 2008
Results First Received: February 3, 2015
Last Updated: October 7, 2015
Health Authority: United States: Food and Drug Administration
Chile: División de Prevención y Control de Enfermedades

Keywords provided by Novartis:
Meningococcal disease
Neisseria meningitidis serogroup B
prevention
vaccination
adolescents

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 06, 2016