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

Meningococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661713
• Other study ID #: V72P10
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 2008
• Est. completion date: December 2010

Study information

• Verified date: March 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1631
• Est. completion date: December 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Meningococcal Disease
• Meningococcal Infections

Intervention

Biological:
• rMenB+OMV NZ

• Placebo

Locations

Country	Name	City	State
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 13: Liceo Diego Aracena de Lo Barnechea	Monseñor Escrivá De Balaguer 14630, Lo Barnechea	Santiago
Chile	Site 12: Colegio San Jose de Lo Barnechea	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Month-1, 2, 3
Primary	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	1 to 7 days after each vaccination
Secondary	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.	Month-6 & 7
Secondary	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.	at baseline, month-1, month-2, month-3, month-6 and month-7.
Secondary	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.	Month-1, month-2, month-3 and month-7
Secondary	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.	month-1, month-2, month-3, month-6 and month-7
Secondary	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.	month-1, month-2, month-3, month-6 and month-7
Secondary	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.	month-1, month-2, month-3, month-6 and month-7
Secondary	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	month-1, month-2, month-3, month-6 and month-7
Secondary	Number of Subjects Reporting Unsolicited AEs Throughout the Study.	Safety was assessed as the number of subjects who reported unsolicited AEs throughout the study.	Throughout the study