Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)

Novartis Vaccines13 sites in 2 countries194 target enrollmentDecember 2013

ConditionsMeningococcal Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Meningococcal Disease
Sponsor: Novartis Vaccines
Enrollment: 194
Locations: 13
Primary Endpoint: 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this extension study is to evaluate the immunogenicity and safety of a booster dose of a MenABCWY vaccine, administered 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180) (Groups I and II). Antibody persistence at 24 and 36 months after the primary vaccination and 12 months after the booster dose will also be evaluated in these subjects.

In addition, safety and immunogenicity of two investigational MenABCWY vaccine formulations (either a MenABCWY+ OMV or a MenABCWY+¼ OMV) will be assessed in subjects who previously received two doses of MenB vaccine (Group III) or one dose of Menveo vaccine (Group IV). These subjects will be followed for safety and immunogenicity for 12 months after vaccination in study V102_03E1.

Registry

clinicaltrials.gov

Start Date

December 2013

End Date

April 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Vaccines

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and females that received both vaccinations and completed the Study Termination visit in the primary study, V102_03 (NCT01272180);
•Individuals or the individual's parents or legal guardian who have given written consent after the nature of the study has been explained according to local regulatory requirements;
•Individuals who have given written assent as required by local regulations after the nature of the study has been explained to them according to local regulatory requirements;
•Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
•Individuals and/or or the individual's parents or legal guardian who can comply with study procedures and are available for follow-up.

Exclusion Criteria

•History of any meningococcal vaccine administration other than the vaccination administered in the primary study, V102_03 (NCT01272180);
•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;
•History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
•All sexually active females that have not used an "acceptable contraceptive method(s)" for at least 2 months prior to study entry. Acceptable birth control methods are defined as one or more of the following:
•Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring)
•Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse
•Intrauterine device (IUD)
•Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry;
•Sexually active females that refuse to use to an "acceptable contraceptive method" through to 3 weeks following the study vaccination;

Outcomes

Primary Outcomes

2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.

Time Frame: Day 1 and Day 30

Percentage of subjects reporting HT-hSBA titers ≥ 1:5 against strains of N. meningitidis serogroups B at baseline (Day 1) and one month (Day 30) following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03 (NCT01272180).

1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y.

Time Frame: Day 30

Percentages of subjects having HT-hSBA seroresponse against N. meningitidis serogroups A, C, W and Y, following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03 (NCT01272180). Seroresponse to N. meningitidis serogroups A, C, W and Y is defined as: for subjects with a pre-vaccination HT-hSBA titer \< 1:4, a post-vaccination hSBA titer ≥ 1:8; for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.

Secondary Outcomes

14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B(Day 1, Day 30 and Day 365)
4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.(Day 1 (Pre vaccination))
3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y.(Day 1 (Pre vaccination))
5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y.(Day 1 (Pre-vaccination))
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.(Day 1, Day 30 and Day 365)
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.(From day 1 (6 hours) through day 7 after any vaccination)
11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.(Day 1 and Day 30)
12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study.(Day 30)
13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.(Day 1 and Day 365)
22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.(Day 1, Day 30 and Day 365)
7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.(Day 1 and Day 30)
8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.(Day 1 and Day 30)
9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.(Day 1 and Day 30)
17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.(Day 1 and Day 365)
20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.(Day 1, Day 30 and Day 365)
6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.(Day 1 (Pre-vaccination))
10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.(Day 1 and Day 30)
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.(Day 1, Day 30 and Day 365)
16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.(Day 1 and Day 365)
18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.(Day 1, Day 30 and Day 365)
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.(Day 1, Day 30 and Day 365)
24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study.(Day 1 through Day 30)
26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination.(From primary parent study completion up to Day 1 in this study.)
25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study.(Day 1 to Day 365)