Clinical trial NCT01992536: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningococcal Disease
Keywords: Meningococcal
Booster
MenABCWY
Menveo
Vaccine Adolescents
Immune Response
N. Meningitidis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 194
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Males and females that received both vaccinations and completed the Study Termination visit in the primary study, V102_03 (NCT01272180);
2. 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;
3. 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;
4. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
5. 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:

1. History of any meningococcal vaccine administration other than the vaccination administered in the primary study, V102_03 (NCT01272180);
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. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
5. 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:

   1. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring)
   2. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse
   3. Intrauterine device (IUD)
   4. Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry;
6. Sexually active females that refuse to use to an "acceptable contraceptive method" through to 3 weeks following the study vaccination;
7. Female subjects with a positive pregnancy test prior to the study vaccine being administered;
8. Nursing (breastfeeding) mothers;
9. Individuals with a history of illness or with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject if he/she participates in the study;
10. 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, blood dyscrasias, bleeding diathesis, signs of cardiac or renal failure, or severe malnutrition);
11. Subjects who required chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the study vaccination. (For corticosteroids, this means prednisone, or equivalent, ≥ 20mg/day. Inhaled and topical steroids are allowed).
12. Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
13. Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study;
14. Administration or planned administration, of any vaccine not foreseen by the study protocol within 30 days prior study vaccination, and up to 30 days after the vaccination (with the exception of any licensed influenza vaccine which may be administered \>14 days preceding or \>14 days following the study vaccination);
15. Individuals who study personnel or immediate family members of study personnel including brother, sister, child, parent, or the spouse.
16. Individuals who have experienced moderate or severe acute infection and/or fever (defined as temperature ≥ 38°C) within 3 days prior to enrolment.
17. Who have received systemic antibiotic treatment within 7 days prior to enrollment.

Primary outcomes:
measure: 1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y.
timeFrame: Day 30
measure: 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
timeFrame: Day 1 and Day 30
Secondary outcomes:
measure: 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y.
timeFrame: Day 1 (Pre vaccination)
measure: 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
timeFrame: Day 1 (Pre vaccination)
measure: 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y.
timeFrame: Day 1 (Pre-vaccination)
measure: 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.
timeFrame: Day 1 (Pre-vaccination)
measure: 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
timeFrame: Day 1 and Day 30
measure: 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
timeFrame: Day 1 and Day 30
measure: 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
timeFrame: Day 1 and Day 30
measure: 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.
timeFrame: Day 1 and Day 30
measure: 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.
timeFrame: Day 1 and Day 30
measure: 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study.
timeFrame: Day 30
measure: 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
timeFrame: Day 1 and Day 365
measure: 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
timeFrame: Day 1, Day 30 and Day 365
measure: 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
timeFrame: Day 1, Day 30 and Day 365
measure: 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
timeFrame: Day 1 and Day 365
measure: 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
timeFrame: Day 1 and Day 365
measure: 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
timeFrame: Day 1, Day 30 and Day 365
measure: 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
timeFrame: Day 1, Day 30 and Day 365
measure: 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.
timeFrame: Day 1, Day 30 and Day 365
measure: 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
timeFrame: Day 1, Day 30 and Day 365
measure: 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.
timeFrame: Day 1, Day 30 and Day 365
measure: 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
timeFrame: From day 1 (6 hours) through day 7 after any vaccination
measure: 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study.
timeFrame: Day 1 through Day 30
measure: 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study.
timeFrame: Day 1 to Day 365
measure: 26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination.
timeFrame: From primary parent study completion up to Day 1 in this study.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 23, Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615
state: Alabama
city: Madera
country: United States
facility: Site 24, Madera Family Medical Group 1111 West 4th Street
state: California
city: Paramount
country: United States
facility: Site 25, Center for Clinical Trials LLC 16660 Paramount Blvd, Suite 301
state: California
city: Bardstown
country: United States
facility: Site 28, Kentucky Pediatric/Adult Research 201 South 5th Street
state: Kentucky
city: Louisville
country: United States
facility: Site 21, Bluegrass Clinical Research Inc. 5512 Bardstown Road, Suite 2
state: Kentucky
city: Dayton
country: United States
facility: Site 26, Ohio Pediatric Research Association 7200 Poe Ave, Suite 200
state: Ohio
city: Kettering
country: United States
facility: Site 27, Ohio Pediatric Research Association 1775 Delco Park Drive
state: Ohio
city: Lebanon
country: United States
facility: Site 22, Focus Research Group 201 Signature Place
state: Tennessee
city: ul.Kościuszki 41
country: Poland
facility: Site 15, Specjalistyczna Przychodnia Lekarska Internistyczno-Pediatryczna, Juniperus" s.c.
state: Izabelin
city: ul. Braci Kiemliczów 14
country: Poland
facility: Site 13, Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska
state: Kraków
city: ul.Strzelców 15
country: Poland
facility: Site 12, NZOZ PRAKTIMED Sp.zo.o
state: Kraków
city: ul. Cegłowska 80
country: Poland
facility: Site 14, Klinika Pediatrii Centrum Medycznego Kształcenia Podyplomowego,Szpital Bielański
state: Warszawa
city: ul.O.Bujwida 44
country: Poland
facility: Site 11, Katedra i Klinika Pediatrii i Chorób Infekcyjnych
state: Wrocław
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References: