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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

April 16, 2008
October 7, 2015
June 2008
April 2010   (final data collection date for primary outcome measure)
  • 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
  • Immunogenicity of one, two or three doses of Novartis Meningococcal B vaccine as measured by percentage of subjects with serum bactericidal activity (SBA) titer ≥ 1:4 at baseline, Month 1, Month 2, Month 3, Month 6 and Month 7 [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Safety of 1, 2 or 3 doses of Novartis MenB Vaccine assessed by frequency of solicited local and systemic reactions collected for 7 days after each study vaccine injection and evaluation of occurrence of AE and SAE during the duration of all the study [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00661713 on ClinicalTrials.gov Archive Site
  • 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.
  • Immunogenicity of 1, 2 or 3 doses of Novartis MenB Vaccine as measured by geometric mean titers (GMTs), geometric mean ratios (GMRs) computed for each visit and meningococcal B strain. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Immunogenicity of 1, 2 or 3 doses of Novartis MenB Vaccine as measured by: % of subjects with a SBA titer ≥ 1:8 measured at baseline, 1, 2, 3, 6 and Month 7; % of subjects with at least a fourfold rise in SBA titer over the pre-vaccination titer [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules
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
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Meningococcal Disease
  • Biological: rMenB+OMV NZ
    Other Name: Serogroup B Meningococcal Vaccine
  • Biological: Placebo
  • 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).
    Interventions:
    • Biological: rMenB+OMV NZ
    • 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).
    Interventions:
    • Biological: rMenB+OMV NZ
    • 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).
    Interventions:
    • Biological: rMenB+OMV NZ
    • 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).
    Interventions:
    • Biological: rMenB+OMV NZ
    • 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).
    Interventions:
    • Biological: rMenB+OMV NZ
    • 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).
    Interventions:
    • Biological: rMenB+OMV NZ
    • 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).
    Interventions:
    • Biological: rMenB+OMV NZ
    • 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).
    Interventions:
    • Biological: rMenB+OMV NZ
    • Biological: Placebo
Santolaya ME, O'Ryan ML, Valenzuela MT, Prado V, Vergara R, Muñoz A, Toneatto D, Graña 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. Erratum in: Lancet. 2015 May 2;385(9979):1728.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1631
December 2010
April 2010   (final data collection date for primary outcome measure)

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.
Both
11 Years to 17 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Chile
 
NCT00661713
V72P10
Not Provided
Not Provided
Not Provided
Novartis Vaccines
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP