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)
2 other identifiers
interventional
194
2 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2013
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
October 25, 2016
CompletedOctober 25, 2016
August 1, 2016
5 months
November 15, 2013
April 14, 2016
August 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y.
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.
Day 30
2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
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).
Day 1 and Day 30
Secondary Outcomes (24)
3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y.
Day 1 (Pre vaccination)
4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
Day 1 (Pre vaccination)
5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y.
Day 1 (Pre-vaccination)
6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.
Day 1 (Pre-vaccination)
7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Day 1 and Day 30
- +19 more secondary outcomes
Study Arms (9)
Ia: MenABCWY+OMV
EXPERIMENTALInvestigational
Ib: Placebo
PLACEBO COMPARATORSaline
IIa: MenABCWY+¼OMV
EXPERIMENTALInvestigational
IIb: Placebo
PLACEBO COMPARATORSaline
IIIa: MenABCWY+OMV
EXPERIMENTALInvestigational
IIIb: MenABCWY+¼OMV
EXPERIMENTALInvestigational
IVa: MenABCWY+OMV
EXPERIMENTALInvestigational
IVb: MenABCWY+¼OMV
EXPERIMENTALInvestigational
IVc: Placebo
PLACEBO COMPARATORSaline
Interventions
Vaccine contains rMenB (50 µg per antigen) with 25 µg of OMV (a "full" dose) plus the fully lyophilized MenACWY vaccine
Vaccine contains rMenB (50 µg per antigen) with 6.25 µg OMV (1/4 dose) plus the fully lyophilized MenACWY vaccine
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- Female subjects with a positive pregnancy test prior to the study vaccine being administered;
- Nursing (breastfeeding) mothers;
- 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;
- 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);
- 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).
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Site 23, Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615
Birmingham, Alabama, 35205, United States
Site 24, Madera Family Medical Group 1111 West 4th Street
Madera, California, 93637, United States
Site 25, Center for Clinical Trials LLC 16660 Paramount Blvd, Suite 301
Paramount, California, 90723, United States
Site 28, Kentucky Pediatric/Adult Research 201 South 5th Street
Bardstown, Kentucky, 40004, United States
Site 21, Bluegrass Clinical Research Inc. 5512 Bardstown Road, Suite 2
Louisville, Kentucky, 40291, United States
Site 26, Ohio Pediatric Research Association 7200 Poe Ave, Suite 200
Dayton, Ohio, 45414, United States
Site 27, Ohio Pediatric Research Association 1775 Delco Park Drive
Kettering, Ohio, 45420, United States
Site 22, Focus Research Group 201 Signature Place
Lebanon, Tennessee, 37087, United States
Site 15, Specjalistyczna Przychodnia Lekarska Internistyczno-Pediatryczna, Juniperus" s.c.
ul.Kościuszki 41, Izabelin, 05-080, Poland
Site 13, Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska
Ul. Braci Kiemliczów 14, Kraków, 31-223, Poland
Site 12, NZOZ PRAKTIMED Sp.zo.o
ul.Strzelców 15, Kraków, 31-422, Poland
Site 14, Klinika Pediatrii Centrum Medycznego Kształcenia Podyplomowego,Szpital Bielański
Ul. Cegłowska 80, Warszawa, 01-809, Poland
Site 11, Katedra i Klinika Pediatrii i Chorób Infekcyjnych
ul.O.Bujwida 44, Wrocław, 50-354, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines and Diagnostics
Study Officials
- STUDY CHAIR
Novartis Vaccines
Novartis Vaccines
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2013
First Posted
November 25, 2013
Study Start
December 1, 2013
Primary Completion
May 1, 2014
Study Completion
April 1, 2015
Last Updated
October 25, 2016
Results First Posted
October 25, 2016
Record last verified: 2016-08