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NCT00297817 Clinical Trial

Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy Adolescents

Meningococcal Disease Clinical Trial

Official title:
A Phase 2, Single-Blind, Controlled, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine ± OMV When Administered at an 0-2-6-Month Schedule in Healthy Adolescents 11-18 Years of Age

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00297817
Other study ID # V72P3
Secondary ID
Status Completed
Phase Phase 2
First received February 27, 2006
Last updated November 30, 2016
Start date February 2006
Est. completion date April 2007

Study information
Verified date January 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and immunogenicity of two serogroup B meningococcal vaccines in comparison to placebo administered to healthy adolescents ages 11 to 18 years.

Recruitment information / eligibility
Status Completed
Enrollment 203
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 11 Years to 18 Years
Eligibility Inclusion Criteria:

- Healthy Adolescents between and including 11-18 years of age, who provide written informed consent.

Exclusion Criteria:

- Previous or suspected disease caused by N. meningitidis; or previous immunization with a serogroup B meningococcal vaccine; Any acute, chronic or progressive disease.

Study Design

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

Related Conditions & MeSH terms

Intervention

Biological:
• serogroup B meningococcal vaccine
0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.
• serogroup B meningococcal vaccine
0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.
• serogroup B meningococcal vaccine
0.5mL doses in pre-filled syringes. All subjects will receive the placebo following a 0,2,6 vaccination schedule.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis Vaccines

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents 1 month after completion of immunization schedule Yes
Secondary Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents 6 months after completion of immunization schedule Yes
See also
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Completed NCT01452464 - Safety of MenACWY-CRM Vaccination in Adolescents N/A
Completed NCT02173704 - Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants of 2 Months of Age and Older, in Taiwan. Phase 3
Completed NCT01682876 - Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age. Phase 3
Recruiting NCT04023929 - Sources of COmplement in Meningococcal and Pertussis Serum Bactericidal Antibody Assays
Completed NCT01453348 - Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine Phase 3
Completed NCT01214837 - Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life Phase 3
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Recruiting NCT04239430 - Propositive (Protecting Positive People From Meningococcal Infection) Follow-up Study
Completed NCT01973218 - Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years. Phase 3
Completed NCT01994629 - Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers Phase 2
Completed NCT01725217 - Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Children, Adolescents and Adults in Russia Phase 3
Completed NCT01717638 - Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1 Phase 3
Completed NCT01466387 - A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults Phase 3
Completed NCT01000311 - A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months Phase 3
Completed NCT02141516 - Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects Phase 3
Completed NCT02140762 - Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents Phase 2
Completed NCT01823536 - Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose Phase 4

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