Phase 2, Observer-Blind, Controlled, Randomized, Multi-Center Extension Study to Evaluate Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY in Adolescents Who Previously Received the Same Study Vaccines

Novartis Vaccines7 sites in 3 countries440 target enrollmentJuly 2011

ConditionsMeningococcal Disease Meningococcal Meningitis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Meningococcal Disease
Sponsor: Novartis Vaccines
Enrollment: 440
Locations: 7
Primary Endpoint: Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate safety, tolerability, and immunogenicity of a booster dose of a meningococcal vaccine formulation in adolescents.

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

July 2012

Last Updated

11 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 were male or female who completed study V102_02 (primary study), and:
•who were 11 to 18 years at the time of enrollment in primary study;
•who had given their written consent at the time of enrollment;
•who were available for all the visits scheduled in the study (ie, not planning to leave the area before the end of the study period);
•who were 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 \>38°C) within the previous 3 days;
•Antibiotics within 7 days prior to enrollment or blood draw;
•Pregnancy or nursing (breastfeeding) mothers;
•Females of childbearing age who had not used or did 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 was 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 (eg, neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, human immunodeficiency virus infection or acquired immunodeficiency syndrome, blood dyscrasias, bleeding 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 or immunostimulants within the previous 60 days. Use of topical corticosteroids administered during the study in limited areas (ie, eczema on knees or face or elbows) of the body was allowed;
•Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;

Outcomes

Primary Outcomes

Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Time Frame: At month 6 and month 7

Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:8 and associated 95% CI, directed against to N meningitidis serogroups A, C, W, and Y at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7).

Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Time Frame: At month 6 and month 7

Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and associated 95% CI, directed against to Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)

Secondary Outcomes

Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo(At month 7)
GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo(At month 6 and month 7)
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo(At month 1, 3, 6, 7 and 12)
Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo(At month 6 and month 7)
Geometric Mean Ratio (GMR) for (95%CI) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo(At month 7)
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo(At month 1, 3, 6, 7 and 12)
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo(At month 1, 3, 6, 7 and 12)
GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo(At month 7)
Percentages of Subjects With Seroresponse Against N Meningitidis Serogroups A, C, W and Y at 1 Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo(At month 7)
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo(At month 1, 3, 6, 7 and 12)
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo(At month 1, 3, 6, 7 and 12)
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo(At month 1, 3, 6, 7 and 12)
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo(At month 1, 3, 6, 7 and 12)
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo(At month 1, 3, 6, 7 and 12)
Numbers of Subjects With Other Unsolicited AEs(Day 8 After vaccination Through Study Termination, up to 6 months)
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination(From Day 1 to Day 7 after vaccination)
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination(From Day 1 to Day 7 after vaccination)