search
Back to results

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

Primary Purpose

Meningococcal Disease

Status
Completed
Phase
Phase 2
Locations
Chile
Study Type
Interventional
Intervention
rMenB+OMV NZ
Placebo
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningococcal Disease focused on measuring Meningococcal disease, Neisseria meningitidis serogroup B, prevention, vaccination, adolescents

Eligibility Criteria

11 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Site 13: Liceo Diego Aracena de Lo Barnechea
  • Site 41: Colegio Antonio Hermida Fabres
  • Site 43: Liceo José Victorino Lastarria
  • Site 51: Centro Para vacunas en Desarrollo. Hospital de Niños Roberto del Rio
  • Site 15: Liceo Carmela Carvajal de Prat
  • Site 14: Colegio Parroquial Santa Rosa de Lo Barnechea
  • Site 42: Centro Educacional Eduardo de la Barra
  • Site 61: Facultad de Medicina. Universidad de Valparaíso.
  • Site 11: Complejo Educacional Eduardo Cuevas Valdés
  • Site 12: Colegio San Jose de Lo Barnechea

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

rMenB06

rMenB0

rMenB016

rMenB01

rMenB026

rMenB02

rMenB012

rMenB6

Arm Description

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).

Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and three injections of placebo (month 1, month 2 and month 6).

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).

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).

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
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
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.
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.
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.
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.
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.
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.
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
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.
Safety was assessed as the number of subjects who reported unsolicited AEs throughout the study.

Full Information

First Posted
April 16, 2008
Last Updated
March 7, 2019
Sponsor
Novartis Vaccines
search

1. Study Identification

Unique Protocol Identification Number
NCT00661713
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Disease
Keywords
Meningococcal disease, Neisseria meningitidis serogroup B, prevention, vaccination, adolescents

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1631 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rMenB06
Arm Type
Experimental
Arm Description
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).
Arm Title
rMenB0
Arm Type
Experimental
Arm Description
Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and three injections of placebo (month 1, month 2 and month 6).
Arm Title
rMenB016
Arm Type
Experimental
Arm Description
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).
Arm Title
rMenB01
Arm Type
Experimental
Arm Description
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).
Arm Title
rMenB026
Arm Type
Experimental
Arm Description
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).
Arm Title
rMenB02
Arm Type
Experimental
Arm Description
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).
Arm Title
rMenB012
Arm Type
Experimental
Arm Description
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).
Arm Title
rMenB6
Arm Type
Experimental
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
rMenB+OMV NZ
Other Intervention Name(s)
Serogroup B Meningococcal Vaccine
Intervention Type
Biological
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
Description
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.
Time Frame
Month-1, 2, 3
Title
Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination
Description
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
Time Frame
1 to 7 days after each vaccination
Secondary Outcome Measure Information:
Title
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.
Description
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.
Time Frame
Month-6 & 7
Title
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
Description
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titer ≥1:8 against 44/76-SL, 5/99, NZ98/254 strains.
Time Frame
at baseline, month-1, month-2, month-3, month-6 and month-7.
Title
Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.
Description
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.
Time Frame
Month-1, month-2, month-3 and month-7
Title
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
Description
Immunogenicity was evaluated by measuring the Geometric mean titers (GMTs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.
Time Frame
month-1, month-2, month-3, month-6 and month-7
Title
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
Description
Immunogenicity was evaluated by measuring the Geometric mean ratios (GMRs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.
Time Frame
month-1, month-2, month-3, month-6 and month-7
Title
GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.
Description
Immunogenicity was evaluated by measuring the Geometric mean Concentration (GMCs) after primary and booster vaccination against Antigen 287-953 Antigen.
Time Frame
month-1, month-2, month-3, month-6 and month-7
Title
GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination
Description
Immunogenicity was evaluated by measuring the Geometric mean Ratios (GMRs) after primary and booster vaccination against 287-953Antigen
Time Frame
month-1, month-2, month-3, month-6 and month-7
Title
Number of Subjects Reporting Unsolicited AEs Throughout the Study.
Description
Safety was assessed as the number of subjects who reported unsolicited AEs throughout the study.
Time Frame
Throughout the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
Site 13: Liceo Diego Aracena de Lo Barnechea
City
Monseñor Escrivá De Balaguer 14630, Lo Barnechea
State/Province
Santiago
Country
Chile
Facility Name
Site 41: Colegio Antonio Hermida Fabres
City
Av. Coronel Alejandro Sepúlveda N° 6801
Country
Chile
Facility Name
Site 43: Liceo José Victorino Lastarria
City
Av. Miguel Claro N° 32
Country
Chile
Facility Name
Site 51: Centro Para vacunas en Desarrollo. Hospital de Niños Roberto del Rio
City
Av. Prof Zañartu 1085
Country
Chile
Facility Name
Site 15: Liceo Carmela Carvajal de Prat
City
Avda. Italia 980
Country
Chile
Facility Name
Site 14: Colegio Parroquial Santa Rosa de Lo Barnechea
City
Avda. Raúl Labbé Nº 13.799
Country
Chile
Facility Name
Site 42: Centro Educacional Eduardo de la Barra
City
Calle A, N° 6301
Country
Chile
Facility Name
Site 61: Facultad de Medicina. Universidad de Valparaíso.
City
Hontaneda # 2653. Valparaíso
Country
Chile
Facility Name
Site 11: Complejo Educacional Eduardo Cuevas Valdés
City
Lo Barnechea
Country
Chile
Facility Name
Site 12: Colegio San Jose de Lo Barnechea
City
Santiago
Country
Chile

12. IPD Sharing Statement

Citations:
PubMed Identifier
33020485
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.
Results Reference
derived
PubMed Identifier
22260988
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. Erratum In: Lancet. 2015 May 2;385(9979):1728.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs