Phase 2, Observer Blinded, Controlled, Randomized Multi-Center Study in Adolescents, to Evaluate Safety, Tolerability and Immunogenicity of Four Different rMenB Plus MenACWY Formulations

Novartis Vaccines8 sites in 3 countries495 target enrollmentDecember 2010

ConditionsMeningococcal Disease Meningococcal Meningitis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Meningococcal Disease
Sponsor: Novartis Vaccines
Enrollment: 495
Locations: 8
Primary Endpoint: Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this phase 2 study is to evaluate the safety, tolerability and immunogenicity of two doses of 4 different investigational MenABCWY combination vaccine when administered to healthy adolescents aged 11-18 years.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

July 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Vaccines

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Individuals eligible to be enrolled into this study are male and female subjects:
•11-18 years at the time of enrollment;
•who have given their written consent/assent and whose parents or legal guardians have given written informed consent at the time of enrollment;
•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);
•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 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 temperature 38C) within the previous 3 days;
•Antibiotics within 7 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 duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), 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, human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (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;

Outcomes

Primary Outcomes

Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs)

Time Frame: 3 months

Percentage of subjects with seroresponse, and human Serum Bactericidal Activity (hSBA) titer ≥ 1:8 and hSBA titer ≥ 1:4 to Neisseria meningitidis serogroups A, C, W-135 and Y

Time Frame: 3 months

Percentage of subjects with hSBA titer ≥ 1:5 to N. meningitidis serogroup B strains

Time Frame: 3 months

Number of participants with solicited local and systemic reactions

Time Frame: within 7 days after each vaccination

Number of participants with any adverse events (AEs)

Time Frame: 6 months

Number of participants with Serious Adverse Events (SAEs)

Time Frame: 3 months